WO2007021496A2 - Systemes et procedes destines a un respect ameliore des soins de sante - Google Patents

Systemes et procedes destines a un respect ameliore des soins de sante Download PDF

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Publication number
WO2007021496A2
WO2007021496A2 PCT/US2006/029420 US2006029420W WO2007021496A2 WO 2007021496 A2 WO2007021496 A2 WO 2007021496A2 US 2006029420 W US2006029420 W US 2006029420W WO 2007021496 A2 WO2007021496 A2 WO 2007021496A2
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WO
WIPO (PCT)
Prior art keywords
patient
compliance
game
substance
code
Prior art date
Application number
PCT/US2006/029420
Other languages
English (en)
Other versions
WO2007021496A3 (fr
Inventor
Jay S. Walker
Patrick W. Nee, Jr.
Carson C.K. Fincham
David Bean
James A. Jorasch
Evan Walker
Rajivan Maniam
Original Assignee
Walker Digital, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/255,240 external-priority patent/US8092224B2/en
Application filed by Walker Digital, Llc filed Critical Walker Digital, Llc
Publication of WO2007021496A2 publication Critical patent/WO2007021496A2/fr
Publication of WO2007021496A3 publication Critical patent/WO2007021496A3/fr

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Classifications

    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising

Definitions

  • a major problem facing the health care industry today is the difficulty of enforcing patient compliance with prescription and health care regimens and therapies All too often, patients ignore the directions associated with their prescriptions, consuming more or fewer pills than recommended by their doctor Many patients simply forget to take the medication for one or more days, resulting in a lengthened healing process
  • Adherence to prescriptions for the treatment of asymptomatic conditions is particularly troublesome Without being reminded of the long-term benefits of a treatment, for example, patients may stop taking a medication when no immediate benefit is apparent (e g , decreased pain or remediation of another obvious symptom)
  • lipid-lowe ⁇ ng medications e g , to lower cholesterol
  • patients taking lipid-lowe ⁇ ng medications may, for example, experience "excess morbidity and mortality' due to noncompliance with prescription regimens Jacobsen, Terry A , M D , "The Forgotten Risk Factor Noncompliance With Lipid-Lowering Therapy', Medscape® Cardiology, www.medscape.com/viewarticle/496144, posted December 22, 2004, at pg. 7.
  • statins 3-hydroxymethylglutaryl-coenzyme inhibitors
  • Lipitor® 3-hydroxymethylglutaryl-coenzyme inhibitors
  • Efforts to promote increased compliance with health care prescriptions and therapies include "[u]sing a warm and caring tone featuring more positive than negative words,” reducing the complexity of treatment regimens, following up with patients that miss appointments, providing e- mail reminders to patients, increasing patient education, and providing reminder, cognitive, and/or self-monitoring aids. Jacobsen, at pg. 6. Such basic tactics have, however, "proved to be complex, labor intensive, and of unreliable effectiveness.” Id., at pg. 5. More advanced approaches and methods have also been presented.
  • U.S. Patent Number 5,641 ,091 to Daneshvar describes a medication-dispensing device that allows a patient to receive his medication on a regular basis. A series of small spaces are arranged in one or more electrically powered rotating trays to allow a proper dose via a window. While this approach makes it easier for a conscientious patient to follow his prescription, forgetful patients may simply let pills "build up" rather than consuming them. Additionally, such devices contain many moving parts that are subject to malfunction and wear. Malfunctions could result in legal liability if the patient was provided access to fewer pills than required by his prescription. A similar dispensing device is described in U.S.
  • Patent Number 5,472,113 to Shaw The automatic pill-dispensing device of Shaw has cartridges rotated via an electric motor, electromagnetic clutches, a rotatable shaft, and gears.
  • a remote third party there is no way for a remote third party to know whether or not the device is operating properly and whether the patient is in fact complying with his prescription.
  • third parties such as hospitals and insurance companies would like to have access to patient prescription compliance data, other devices have been created to store data such as how often a pill container has been opened or the time and date that it was opened.
  • FIG. 1 is a block diagram of a system according to some embodiments
  • FIG. 2 is a flow diagram of a method according to some embodiments
  • FIG. 3 is a block diagram of a compliance module according to some embodiments.
  • FIG. 4A, FIG. 4B, and FIG.4C are block diagrams of data tables according to some embodiments.
  • FIG. 5A is a perspective diagram of a compliance module according to some embodiments.
  • FIG. 5B is a plan view of a compliance module according to some embodiments.
  • FIG. 6 is a perspective cross-sectional diagram of a system according to some embodiments.
  • FIG. 7 is a plan view of a compliance module according to some embodiments.
  • FIG. 8 is a flow diagram of a method according to some embodiments;
  • FIG.9 is a block diagram of a controller according to some embodiments.
  • FIG. 1OA, FIG. 1OB, and FIG. 1OC are block diagrams of data tables according to some embodiments.
  • Some embodiments described herein generally relate to medicine containers, medicine applicators, medicine dispensers, medical equipment, prescription medications, health care regimens or therapies, and methods for improving compliance with prescriptions and health care regimens or therapies More particularly, some embodiments relate to systems and methods for documenting and authenticating patient compliance with health care regimens, and some embodiments facilitate improvement of patient compliance
  • the term “patient” may generally refer to any individual, entity, or other being associated with a prescription, therapy, or other health care regimen Patients may, for example, be persons seeking and/or obtaining preventative, therapeutic, and/or remedial health care treatment
  • the terms “prescription”, “therapy”, ' regimen”, and “health care regimen” may be used interchangeably and may generally refer to any plan, strategy, requirement, treatment, and/or other condition, procedure, or act associated with the health of a patient
  • Prescriptions may be oral and/or written by a health care professional, for example, and filled by the patient to obtain medications, pills, vitamins, dietary supplements, and/or other health-related devices, objects, or substances
  • the terms "substance” may generally refer to any quantity or amount of a health-related material that may be depleted, expended, and/or otherwise utilized via the effectuation of a prescription, therapy, or regimen
  • examples of some such substances may include, but are not limited to, pills, liquid medications, foods, drinks, ointments, patch-applied medications, inhalants, test strips, and batteries for health care devices
  • the "taking" of a substance may refer to the ingestion (e g , by a patient) of a pill or medication, the application of a medicated patch, and/or the depletion of a medication or battery (or other energy source) associated with a medical, treatment, therapeutic, and/or exercise device
  • some embodiments herein are associated with “compliance” or "adherence” to, or ' acceptance” of, a prescription, therapy, or other health care regimen
  • the terms “compliance”, adherence , and “acceptance” may be used interchangeably to refer to an extent to which a patient's actions coincide with those actions specified by and/or associated with the prescription, therapy, and/or other health care regimen
  • compliance may be a dichotomous or Boolean value (e g , true or false, compliant or noncompliant), while in other embodiments compliance may comprise a continuum
  • Different patients may, for example, be more or less compliant than others Patients may also or alternatively be grouped according to one or more compliance variables
  • the percentage of time that a patient takes the appropriate doses and/or the frequency or magnitude of compliance with dosage schedules may, for example, be utilized to develop or define ranges of values within which patients may be grouped or classified (i.e., in terms of compliance).
  • a “user device” or a “network device” may be used interchangeably and may generally refer to any device that can communicate via a network.
  • user or network devices include a Personal Computer (PC), a workstation, a server, a printer, a scanner, a facsimile machine, a copier, a Personal Digital Assistant (PDA), a storage device (e.g., a disk drive), a hub, a router, a switch, and a modem, a video game console, or a wireless phone.
  • PC Personal Computer
  • PDA Personal Digital Assistant
  • Storage device e.g., a disk drive
  • a hub e.g., a router, a switch, and a modem
  • video game console e.g., a wireless phone.
  • User and network devices may comprise one or more communication or network components.
  • network component may refer to a user or network device, or a component, piece, portion, or combination of user or network devices.
  • network components may include a Static Random Access Memory (SRAM) device or module, a network processor, and a network communication path, connection, port, or cable.
  • SRAM Static Random Access Memory
  • network or a “communication network”.
  • network and “communication network” may be used interchangeably and may refer to any object, entity, component, device, and/or any combination thereof that permits, facilitates, and/or otherwise contributes to or is associated with the transmission of messages, packets, signals, and/or other forms of information between and/or within one or more network devices.
  • Networks may be or include a plurality of interconnected network devices.
  • networks may be hard-wired, wireless, virtual, neural, and/or any other configuration of type that is or becomes known.
  • Communication networks may include, for example, one or more networks configured to operate in accordance with the Fast Ethernet LAN transmission standard 802.3-2002® published by the Institute of Electrical and Electronics Engineers (IEEE).
  • a network may include one or more wired and/or wireless networks operated in accordance with any communication standard or protocol that is or becomes known or practicable.
  • information and “data” may be used interchangeably and may refer to any data, text, voice, video, image, message, bit, packet, pulse, tone, waveform, and/or other type or configuration of signal and/or information.
  • Information may comprise information packets transmitted, for example, in accordance with the Internet Protocol Version 6 (IPv6) standard as defined by “Internet Protocol Version 6 (IPv6) Specification” RFC 1883, published by the Internet Engineering Task Force (IETF), Network Working Group, S. Deering et al. (December 1995).
  • IPv6 Internet Protocol Version 6
  • IETF Internet Engineering Task Force
  • Information may, according to some embodiments, be compressed, encoded, encrypted, and/or otherwise packaged or manipulated in accordance with any method that is or becomes known or practicable.
  • an "indication” may be used to refer to any indicia and/or other information indicative of or associated with a subject, item, entity, and/or other object and/or idea.
  • the phrases "information indicative of and “indicia” may be used to refer to any information that represents, describes, and/or is otherwise associated with a related entity, subject, or object.
  • Indicia of information may include, for example, a code, a reference, a link, a signal, an identifier, and/or any combination thereof and/or any other informative representation associated with the information.
  • indicia of information (or indicative of the information) may be or include the information itself and/or any portion or component of the information.
  • an indication may include a request, a solicitation, a broadcast, and/or any other form of information gathering and/or dissemination.
  • the system 100 may comprise and/or be associated with, for example, a user 102, a compliance module 110, a user device 140, a controller 150, and/or a network 180.
  • the compliance module 120 may be configured to identify, detect, measure, determine, and/or encode indications of health care-related events associated with the user 102.
  • the compliance module 110 may, for example, detect pill bottle cap removals, movements of a pill bottle, dispensing of a liquid, application of a medicated patch, use of a therapeutic and/or exercise device, removal of a pill from a blister pack, and/or other prescription, therapy, and/or health care regimen-related events.
  • the compliance module 110 may also or alternatively, according to some embodiments, be configured to provide game-related information to the user 102.
  • the user 102 may be motivated to take a medication and/or to more closely adhere to a regimen, for example, by receiving game-related (and/or other motivational) information via the compliance module 110.
  • the event data associated with the user 102 may be encoded and/or encrypted by the compliance module 110 and a resulting code and/or information may be provided to the user 102.
  • the user 102 may then, for example, utilize the user device 140 to communicate the code or information (e.g., encoded information indicative of the health care-related event) to the controller 150 (e g , via the network 180)
  • the user device 140 may, according to some embodiments, be any type or configuration of network device that is or becomes known or practicable
  • the user device 140 may, for example, comprise a telephone (e g , wired or wireless) and/or other communication device associated with the user 102
  • the controller 150 may, according to some embodiments, utilize the encoded and/or encrypted information to determine if the user 102 is compliant with a prescription, therapy, and/or other health care regimen
  • the user 102 may, for example, be a patient, and/or the controller 150 may be owned, operated by, and/or otherwise associated with a health care provider, an
  • the compliance module 110 may include elements (such as electronic elements) incorporated within the cap of a prescription medication, food, or drink container, although it could also or alternatively take the form of an add-on module coupled or attached to either the container cap or the container itself
  • the compliance module 110 may be used in conjunction with a pill-dispensing device that is operated to vend pills
  • a system capable of holding a plurality of prescriptions could also incorporate the functionality of the compliance module 110
  • the compliance module 110 may be or include a device that does not dispense or contain a prescription and/or other substances
  • the compliance module 110 may, for example, comprise a pressure-sensitive pad upon which medicine containers are placed or a medical identification bracelet and/or other device capable of electronically detecting or sensing health care-related substances, containers, or other associated apparatus
  • the compliance module 110 may comprise and/or be coupled to an exercise device (such as a treadmill) to monitor a patient s exercise routines and/or health-related metrics (e g heart rate)
  • a user 102 may employ the compliance module 110 to measure and document the number of times that an openable or reclosable cap, lid, or other similar dispensing covering is removed from an associated substance container
  • the container may be equipped, for example, with a detector that generates a first electrical signal in response to the opening of the dispensing covering and also or alternatively a second electrical signal in response to the reclosing
  • cap removal data In accessing the container by removing or replacing the cap, the user 102 may cause cap removal data to be generated and the data may be stored as a numeric value (e g , via the compliance module 110 and/or components thereof)
  • This cap removal data may be (or be indicative of) the total number of times that the cap is removed in a given time period, the number of days in which the cap is removed more than once, the number of days in which the cap is not removed, the average number of removals per day, etc
  • compliance module 110 may store chronographic data regarding the timing of the removals Such chronographic data may include the date/time of each removal, the average time of day of all removals over a particular period, the average number of hours between each removal, etc
  • the compliance module 110 may receive the cap removal data from cap removal sensors, and may encode the data, thereby generating encoded cap removal data In some embodiments,
  • the controller 150 may, according to some embodiments, decode the received encoded data and store the resulting decoded information
  • an entity such as a health care-related entity
  • the number of times that the user 102 removes the cap of a pill bottle, for example, may be determined via the encoded information, thereby providing greater assurance that the user 102 has consumed a prescribed medication.
  • Such compliance data may be used to lower insurance premiums in much the same way that motorists are rewarded with lower car insurance premiums for wearing safety belts.
  • the controller 150 may also or alternatively decode and/or receive the information to determine actions associated with one or more games, Patients determined to meet certain compliance criteria, for example, may be entered into sweepstakes, lotteries, and/or other games of chance or skill.
  • the controller 150 may, for example, provide a compliant patient with one or more lottery tickets or numbers as a reward for attaining compliance.
  • the controller 150 may analyze and/or otherwise process the information to determine one or more actions or results associated with a game.
  • a patient may, for example, provide the controller 150 with information (which may be encoded) that indicates that the patient has won a game or prize.
  • the controller 150 may award and/or provide a prize to the patient.
  • compliance and/or game information from multiple patients may be compared.
  • Patients belonging to and/or assigned to certain groups e.g., members of the same health insurance group, members of the same company, and/or residents of the same assisted living facility
  • patients belonging to and/or assigned to certain groups may be ranked, for example, to determine which patients should be awarded prizes and/or benefits (e.g., based on compliance and/or game results).
  • a flow diagram of a method 200 is shown.
  • the method 200 may be performed and/or implemented by and/or otherwise associated with the compliance module 120 described in conjunction with FIG. 1.
  • the flow diagrams described herein do not necessarily imply a fixed order to the actions, and embodiments may be performed in any order that is practicable.
  • any of the methods described herein may be performed by hardware, software (including microcode), firmware, or any combination thereof.
  • a storage medium may store thereon instructions that when executed by a machine result in performance according to any of the embodiments described herein.
  • the method 200 may begin by identifying an occurrence of an event associated with the taking of a substance by a patient, at 202
  • the compliance module 120 may, for example, accumulate and/or store data indicating that the cap of a container has been removed (e g , the cap of a prescription medication bottle or a lid to a dietary supplement container)
  • data may be received via signals from a sensor such as a switch that is physically engaged (and/or a circuit that is otherwise opened or closed) when the container cap is removed or replaced
  • Sensors may generate data for either or both of removals and replacements
  • this data may be stored in one or more data tables as are described in more detail elsewhere herein
  • data regarding every cap removal and/or other event may be stored, although data could of course be selectively stored if memory limitations are a constraint For example, every fifth cap removal and/or other event may be stored and/or every cap removal and/or event occurring during certain pre-defined time periods (e g , between the
  • other event occurrences may also or alternatively be identified, detected, and/or otherwise determined
  • an event may be indicated by the breaking of a seal to remove one or more units of the substance
  • the removal of an adhesive backing cover of a medicated patch (such as a Nicotrol® or NicoDerm® nicotine patch) may also or alternatively define such an event
  • the actual usage, ingestion, and/or other application of the substance may be determined
  • signals may be sent and/or received (e g , via the patient's body) to determine that the medicated patch has been applied to the patient's skin
  • the compliance module 110 may, for example, comprise a medical information bracelet, tag, and/or device (such as a MedicAlert® bracelet or E-HealthKeyTM) that may detect signals sent through and/or via a patient's body (e g , indicating application of a medicated patch and/or ingestion or application of a medication)
  • the compliance module 110 may comprise a necklace, earring, and/or other device capable of detecting proximity of a pill
  • Each pill to be taken by a patient may, for example, be coupled with a Radio Frequency IDentification (RFID) device that a compliance necklace may detect upon swallowing by a patient
  • RFID device on the pill may only be activated upon exposure to saliva so that false swallow indications may be less likely
  • a patient may be supplied with more than one compliance device and/or more than one potential compliance device so that the patient may be less likely to be able to falsify compliance data
  • a patient may be supplied with a compliance- tracking pill bottle (and/or cap) as well as a compliance-tracking bracelet, for example
  • both compliance devices may record and track events and the data may be compared to verify accuracy, identify errors, and/or discover tampering efforts.
  • tracking may be alternated (e.g., randomly and/or in accordance with a pre-defined pattern) between the devices, so that the patient may not be aware which device is actively tracking compliance data at any given time.
  • movement, proximity, and/or other metrics associated with a substance and/or substance container may be determined.
  • a pressure-sensitive pad (such as a "compliance pad” as described herein) may, for example, be utilized to determine if a container is picked-up, moved, and/or if a quantity of a substance has been removed from the container (e.g., such as in the case that the pad may be capable of detecting or measuring mass, weight, or other forces or metrics).
  • a sensor and/or circuit may be utilized to detect the immersion of a syringe into a particular substance.
  • the immersion may, for example, complete a circuit and/or alter a voltage or resistance/impedance in a particularly pre-defined manner that indicates immersion into a substance having certain properties.
  • an accelerometer and/or other sensor may detect pill bottle cap removals and/or movements, and/or may detect the shaking of a vial (e.g., which may be required prior to ingestion of a medication contained therein).
  • compliance with a condition associated with the taking of the substance may be determined and/or analyzed. Whether an identified event occurrence is compliant with, satisfies (and/or partially satisfies), and/or is otherwise associated with a condition such as a prescription, therapy, and/or regimen condition, may, for example, be determined (e.g., by the compliance module 110 and/or by another device or entity). In some embodiments, an indication of such compliance may be generated and/or stored. The indication may, for example, be indicative of whether or not a condition associated with the taking of the substance is satisfied and/or complied with. Cap removal data may, for example, represent an indication of whether or not a container cap is removed within the parameters described by a prescription.
  • a stored indication of such an event may, according to some embodiments, comprise a positive value in the case that the patient removes the cap once every day between the hours of 3:00 PM and 9:00 PM, and may comprise a negative value in the case that one or more days elapse in which the cap is not removed within the appropriate time window. Any other values (such as values indicating partial compliance) that are or become practicable may also or alternatively be generated and/or stored.
  • an indication of the compliance status may be provided to the patient and/or to another entity.
  • the patient may, for example, press a button on the compliance module 110 to indicate a request for the current compliance status.
  • the status may then be indicated to the patient, for example, via one or more displays, sounds, and/or visual indicators (e g , lights)
  • one or more Light-Emitting Diode (LED) devices may be utilized to indicate the current compliance status
  • a green LED may indicate compliance, for example, while a red LED may indicate non-compliance
  • a yellow or orange LED may indicate partial compliance and/or near non-compliance
  • a value of a compliance metric may be provided (e g , via voice, sounds, and/or via a display device)
  • the text ' 90%" may, for example, be displayed to the patient to indicate that the patient is currently ninety percent compliant (e g , with respect to when
  • the compliance module 110 may actively provide an indication of compliance to the patient
  • the compliance module 110 comprises a device capable of receiving signals from a heart rate monitor
  • the compliance module 110 may provide indications to the patient associated with the patient's current heart rate (e g , during exercise)
  • the compliance module 110 may also or alternatively act to affect the patient's heart rate and/or other compliance-related metric, such as by altering the difficulty, slope, and/or speed of a treadmill to actively tailor the patient's workout to comply with one or more health care and/or exercise regimens (with or without the patient's knowledge or awareness)
  • the provided indication may also represent other data
  • a patient may press a button to receive an indication as to the status of a game, for example
  • the method 200 may continue, according to some embodiments, by determining output information associated with a game, at 204
  • the output may be determined, for example, to facilitate improved compliance with a patient's prescription regimen
  • the output may be determined based on a prescription regimen
  • the game output may be determined to coincide with the prescription window (e g , may be determined, near, and/or before 4 00 PM)
  • the output may be determined based on the occurrence of the event (and/or the identification of the occurrence) Every time a patient opens a container associated with a substance, for example, the output may be generated and/or otherwise determined
  • the output may be determined only in the case that the occurrence of the event is in compliance with the prescription It may not be desirable, for example, to determine game output unless a patient's actions are in conformance with a health care regimen
  • the output may comprise a code that may be determined to be indicative of the occurrence of the event.
  • the code indicative of the event may, for example, be coded and/or encrypted to resemble a form of game output such as a bingo number, a lottery number, and/or any other type or form of code, coordinate, and/or game-related data.
  • a code may be utilized both to indicate compliance (or non-compliance) with a prescription and to determine one or more actions or outcomes related to a game.
  • codes generated to be indicative of non-compliant events may be utilized and/or effective as "losing" and/or otherwise negative result-oriented game output, for example, while codes indicative of compliant events may be utilized and/or effective as "winning" and/or positive result-oriented games output.
  • patients that are compliant may be more likely to win a game (e.g., associated with the compliance module 110), while non- compliant (and/or less compliant) patients may be less likely to achieve positive game results.
  • the compliance module 110 may be provided with information associated with a game (such as the layout of a bingo, minesweeper, and/or battleship board) to facilitate generation of "winning" and/or "losing" game outputs.
  • the amount, quantity, and/or type of game output may also or alternatively be based on the occurrence of the event and/or an associated prescription.
  • the probability of achieving a winning result via the game output may be based on a patient's compliance. More compliant patients may be entered into a first, smaller drawing or sweepstakes, for example, providing each such compliant patient with relatively high chances of winning. While less compliant patients may be entered into a second, larger drawing or sweepstakes, providing each such patient with larger (or worse) odds of achieving a winning result. Payout tables and/or other metrics utilized to determine the game output may also or alternatively be managed, manipulated, and/or altered based on a patient's compliance.
  • the quantity of game output may be managed.
  • the game output comprises one or more bingo numbers
  • more bingo numbers may be provided to patients achieving higher compliance, while non-compliant and/or minimally compliant patients may not receive any bingo numbers.
  • the quantity of game output may be varied in accordance with one or more prescription frequencies. In the case that only one bingo number is provided every time a patient takes a pill, for example, even among patients of equal compliance, those patients with higher frequency prescription doses may have an advantage (e.g., receiving more game output may increase chances of winning).
  • Patients required to take a pill every day may receive thirty (30) bingo numbers a month, for example, while patients only required to take a pill once a week may only receive four (4) bingo numbers a month.
  • a desirable amount of output per time period may be determined.
  • the amount of game output to be determined may be calculated by the following formula:
  • the method 200 may continue, according to some embodiments, by providing the output information to the patient, at 206.
  • the game output determined at 204 may be displayed, transmitted, and/or otherwise provided to the patient. According to some embodiments, a subset of the game output determined at 204 may be provided to the patient.
  • the game output may only be provided to the patient if the event is determined to be in compliance with a prescription. This may prevent, for example, a patient from obtaining more game output by simply opening and closing a pill bottle repeatedly, when not required to do so by a prescription.
  • particular game output that is determined at 204 may be selected for providing to the patient. Multiple game output may be determined for various circumstances such as compliance, partial compliance, or non-compliance, for example, and based on a determination of a patient's compliance, the corresponding and/or appropriate game output may be selected to be provided to the patient.
  • the output information may be directly displayed to the patient.
  • the compliance module 110 may, for example, comprise a display device capable of providing images and/or other data to the patient. Any code or other game or compliance-related information may be displayed via such a device for viewing by the patient.
  • the output may also or alternatively be transmitted to one or more other devices.
  • One or more devices associated with the patient may, for example, receive the output. Such devices may include, but are not limited to, a computer, a PDA, a watch, a TV, a telephone, a pager, and/or any combination of these and/or other device associated with the patient.
  • the patient may then utilize the device to provide the information to a system (such as the controller 150) and/or entity that may provide rewards to the patient based at least in part on the patient's compliance and/or upon the game output.
  • the output may be otherwise provided to the patient.
  • the output may be spoken, sounded, and/or provided via blinking lights and/or other indicators, for example.
  • the output may comprise sound and/or tone output that a patient may simply provide to a telephone (e.g., by holding a compliance module near the receiver) such that the information may be automatically transmitted to another device such as a controller.
  • the game output provided to the patient may comprise information not directly associated with a typical "game".
  • the game output may comprise, for example, animated representations of an artificial creature and/or an artificial intelligence (e.g., a TamagotchiTM).
  • an artificial intelligence e.g., a TamagotchiTM.
  • the occurrence of a patient's prescription-compliant events may be necessary, for example, for a patient to maintain the "health" and/or "life” of a displayed and/or rendered cyber-pet.
  • Patients that are compliant and/or substantially compliant for example, may be presented with game output indicating that their "pet” has grown, learned more skills or words, and/or is otherwise doing well.
  • Non-compliant patients may be presented with game output indicating that the "pet” is hungry, sick, or even dying.
  • a "pet” may be shown to suffer maladies and/or symptoms consistent with common problems the patient may suffer if medications or treatment regimes are not followed properly (e.g., as foreshadowing of what may occur if the patient does not improve compliance),
  • the game output provided to the patient may comprise various sounds, pictures, and/or other media (e.g., video) intended to motivate the patient to comply with a prescription.
  • Such media may comprise, according to some embodiments, pictures of friends, family members, or celebrities (and/or other desirable and/or motivational pictures) or sounds and/or voice recordings of friends, family members, or celebrities (and/or other motivational sounds or voice like "Good Job!).
  • a patient's complaint actions may, for example, cause pictures of grandchildren to be displayed and/or pre-recorded voice tracks from a spouse or other loved-one to be played (e.g., as positive motivation).
  • non-compliant events may trigger a direct cellular telephone and/or other communication with a family member and/or health care provider so that the patient may be provided with live support to facilitate and/or encourage compliance.
  • the pictures and/or portions thereof may fade and/or disappear in response to non-compliance by a patient.
  • a picture and/or representation or indication of an available prize (such as a picture of a tropical island representing an available prize trip to Hawaii), for example, may be displayed.
  • the displayed prize picture may fade in relation to decreased and/or diminished compliance of a patient (e.g., indicating that the patient's chance of winning the prize is "slipping away").
  • the game output may be provided to stimulate other senses.
  • the game output may comprise, for example, an olfactory indicator such as a pleasing scent.
  • the olfactory indicator may comprise one or more scents associated with an aromatherapy treatment or may otherwise be configured to facilitate compliance by pleasing or alerting a patient's sense of smell.
  • the scent may, for example, be configured to remind the patient of a pleasing experience and/or to otherwise indicate that the time has come to take a pill or perform a treatment action.
  • the compliance module 310 may be similar in configuration and/or functionality to the compliance module 110 described in conjunction with FIG. 1.
  • the compliance module 310 may, for example, be utilized to monitor and/or record prescription- related events and/or to provide game output to patients to facilitate improved prescription compliance,
  • the compliance module 310 may also or alternatively execute, process, and/or otherwise be associated with the method 200 described in conjunction with FIG. 2.
  • the compliance module 310 may comprise a processor 312, a sensor 314, a clock 316, an input device 318, an output device 320, and/or a data storage device 322.
  • the data storage device 322 may store encoding process instructions 324, game instructions 326, event data 330, condition data 332, and/or game data 334. In some embodiments, fewer or more components, instructions, and/or data than are shown in FIG. 3 may be included in the compliance module 310.
  • the processor 312 may be or include any type, quantity, and/or configuration of processor that is or becomes known.
  • the processor 312 may comprise, for example, an Intel® IXP 2800 network processor or an Intel® XEON TM Processor coupled with an Intel® E7501 chipset.
  • the processor 312 may comprise multiple interconnected processors, microprocessors, and/or micro-engines.
  • the processor 312 (and/or the compliance module 310 and/or other components thereof) may be supplied power via a power supply (not shown) such as a battery, an Alternating Current (AC) source, a Direct Current (DC) source, an AC/DC adapter, solar cells, and/or an inertial generator.
  • a power supply not shown
  • a battery such as a battery, an Alternating Current (AC) source, a Direct Current (DC) source, an AC/DC adapter, solar cells, and/or an inertial generator.
  • AC Alternating Current
  • DC Direct Current
  • solar cells and/or an
  • a Lithium-ion (Li-ion), Nickel Cadmium (NiCad), and/or Nickel Metal Hydride (NiMH) battery may, for example, supply the necessary voltage and/or amperage to power any or all of the components of the compliance module 310.
  • the processor 312 may receive signals from the sensor 314.
  • the sensor 314 may, for example, comprise one or more sensors configured and/or coupled to identify, detect, and/or otherwise determine the occurrence of an event associated with the taking of a substance by a patient
  • the sensor 314 may, according to some embodiments, comprise a switch that is coupled to engage in the case that a cap and/or top to a container is opened and/or to disengage in the case that the cap and/or top is closed, latched, and/or otherwise secured
  • the sensor 314 may supply the processor 312 with an indication of the number of times that the cap and/or top has been removed and/or replaced
  • Any type, quantity, and/or configuration of sensor 314 that is operable to identify, detect, and/or otherwise determine the occurrence of a prescription- related event may be utilized Electrical, electronic, magnetic, and/or mercury switches, pressure sensors, stress sensors, motion sensors, weight sensors, light sensors (including lasers), thermal sensors, acoustic sensors, triggers, gates, switches, barcode or other electronic readers and/or scanners, signal receivers, and/or any other type of sensing device that is or becomes practicable may, for example, comprise the sensor 314
  • sensors 314 may include, but are not limited to, those described in U S Patent No 4,939,705 to Hamilton, et al and U S Patent No 4,616,316 to Hanpeter et al , which are incorporated by reference herein
  • the type of sensor described by Hanpeter for example, consists of a blister pack with an array of plastic blisters that define compartments for medication
  • the backing sheet comprises conductive traces that are respectively ruptured when the medication doses are removed
  • An electronic memory circuit detects the ruptures and stores the data over a period of time
  • Other types of sensors 314 may also or alternatively be used
  • the sensor 314 may, for example, compnse a passive-inductive device, a RF receiver, and/or an RFID reader and/or device
  • the sensor 314 may, for example, be operable to receive signals from, identify, and/or detect a prescription-related device (such as a medicine bottle or container) and/or may be operable to measure metrics associated therewith (e g , location identification, position
  • the sensor 314 may transmit the data to the processor 312 a fixed number of fimes within a given time period For example, a maximum number of transmitted cap removals and/or other events within a twenty-four (24) hour period might be two Such a restriction would make it impossible for a patient to generate false cap removal data (e g , in the case of a pill bottle) by repeatedly opening and closing the cap within a short period of time A patient with a month long prescription, for example, might realize at the end of the month that he had forgotten to take his medication Trying to generate a month's worth or cap removal data would be futile since only two cap removal events would be recorded within each twenty four hour period
  • the compliance module 310 may include the clock 316
  • the clock 316 may, for example, facilitate the compilation, generation, and/or storage of time-related data
  • the clock 316 may maintain an internal (e g , with respect to the compliance module 310) representation of the time/date and may be used to provide a timestamp that may augment the data provided by the sensor 314
  • the clock 316 may, for example, be used to track time of day, date, day of week or any other type or configuration of chronographic measurement that is or becomes known
  • the clock 316 may provide one or more clock signals to the processor 312 and/or the sensor 314 to synchronize, coordinate, manage, and/or facilitate data transmissions and/or analysis
  • the clock 316 may be incorporated as part of the processor 312
  • the clock 316 may, for example, comprise an on-chip or on-d ⁇ e clock circuit incorporated as part of a Central Processing Unit (CPU) that also includes the processor 312
  • the clock 316 may comprise an external source that provides time-related data to the compliance module 310 and/or components thereof
  • the clock 316 may, for example, comprise a device associated with receiving and/or providing standardized time information such as that obtainable from an atomic and/or atomic fountain clock like the National Institute of Standards and Technology-F1 (NIST-F1) cesium fountain atomic clock located in Boulder, Colorado, that defines Coordinated Universal Time (' UTC”)
  • the compliance module 310 may comprise the input device 318
  • the input device 318 may be or include any type, quantity, and/or configuration of input device that is or becomes known or practicable
  • the input device 318 may comprise, for example, a keyboard, a keypad, a pointing device (such as a mouse or trackball), one or more buttons or switches, a biomet ⁇ c device, such as a fingerprint or retinal scanner, a magnetic card reader or smart card reader, and/or one or more softkeys and/or variable function input devices
  • the input device 318 may be utilized by a patient to provide information to the compliance module 310 The patient may provide (and/or the compliance module 310 may otherwise receive), for example, input such as a user identifier, a cap, container, and/or "compliance pad" identifier, an insurance policy identifier, and/or a prescription identifier.
  • the input device 318 may comprise voice recognition capability to allow a patient (and/or other user or entity) to provide verbal information to the compliance module 310.
  • the patient may, for example, speak a code word and/or provide other voice input to the input device 318.
  • the input device 318 may then provide an indication of such input to the processor 312 (e.g., for patient identification and/or other purposes).
  • the compliance module 310 may also or alternatively comprise the output device 320.
  • the output device 320 may, for example, be or include any type of output device that is or becomes known or practicable. Examples of output devices 320 may include, but are not limited to, a printer, a speaker, a modem, a Network Interface Card (NIC), a port, a path, a cable, a Cathode Ray Tube (CRT) display device, a Liquid Crystal Display (LCD) device, and/or an LED display device.
  • information associated with any of the processor 312, the sensor 314, the clock 316, and/or the input device 318 may be provided, transmitted, and/or displayed via the output device 320.
  • the output device 320 may, for example, comprise a display screen to provide various information to a patient and/or other entity. In some embodiments, the output device 320 may be utilized to provide information processed by the processor 312 and/or information stored via the data storage device 322.
  • the data storage device 322 may, for example, store the encoding process instructions 324 and/or the game instructions 326 that may be utilized by the processor 312 to provide output information via the output device 318.
  • the data storage device 322 may comprise any appropriate information storage device that is or becomes known or available, including, but not limited to, units and/or combinations of magnetic storage devices (e.g., a hard disk drive), optical storage devices, and/or semiconductor memory devices such as Random Access Memory (RAM) devices, Read Only Memory (ROM) devices, Single Data Rate Random Access Memory (SDR-RAM) 1 Double Data Rate Random Access Memory (DDR-RAM) 1 and/or Programmable Read Only Memory (PROM).
  • RAM Random Access Memory
  • ROM Read Only Memory
  • SDR-RAM Single Data Rate Random Access Memory
  • DDR-RAM Double Data Rate Random Access Memory
  • PROM Programmable Read Only Memory
  • the encoding instructions 324 may be operable to cause the processor 312 to encode information.
  • Information received from any of the sensor 314, the clock 316, and/or the input device 318 may, for example, be encoded by the processor 312 in accordance with the encoding instructions 324.
  • Encoding data may provide many advantages. Without knowing how the data is encoded, for example, a patient and/or other entity (e.g., other than a decoding entity) may not be able to (or may not be easily able to) falsify the data. In the case that the data is indicative of prescription-related events and/or game information, for example, encoding may facilitate accurate and secure storage and/or transmission of compliance and/or reward-related information.
  • the encoding process instructions 324 may comprise, according to some embodiments, one or more encoding and/or encryption protocols to be utilized in encoding data. Examples of various encoding and/or encryption protocols that may be utilized include symmetric key encryption, public key encryption, hash algorithms, digital signatures, and the like. If lower levels of security are required, substitution ciphers or transposition ciphers may be appropriate. Common types of encoding are described in "Applied Cryptography, 2nd Edition" by Bruce Schneier (1996), the encoding and/or encryption descriptions of which are incorporated herein.
  • the data encoded by the processor 312 may comprise prescription compliance information.
  • the number of cap, top, and/or lid removals in a given time period may, for example, be encoded by the processor 312.
  • other data may also or alternatively be encoded. Examples of other data may include user identifiers, cap and/or container identifiers, insurance identifiers, account identifiers, compliance module 110, 310 identifiers, a beginning timestamp and an ending timestamp.
  • the patient may, for example, enter the number of pills that are taken at each cap removal event, entering the information via the input device 318.
  • a cap identifier (and/or other information) may be concatenated and/or otherwise combined with the cap removal data.
  • the resulting combined data may then, for example, be encoded by the processor 312.
  • One advantage of such an embodiment is that when the encoded cap removal data is decoded, the identity of the cap (and/or patient, compliance module 310, etc.) may be authenticated in addition to the number of cap removals, preventing a user from providing the encoded cap removal data from another patient's compliance module 310.
  • the encoding process instructions 324 may also provide instructions associated with an integrity test.
  • An indication of a security breach (e.g., tampering) associated with the compliance module 310 may be concatenated and/or otherwise included with the cap removal data prior to the encoding process, for example. Decoding may subsequently reveal evidence of the breach (e.g., and be used to invalidate the compliance results).
  • the game instructions 326 may be operable to cause the processor 312 to execute and/or otherwise process data in accordance with one or more games.
  • the processor may execute the game instructions 326 to provide game-related data to the patient (e.g., via the output device 320).
  • the game instructions 326 may include complete code capable of executing, performing, and/or rendering an entire game.
  • the game instructions 326 may simply comprise instructions associated with game output (e.g., moves, actions, and/or coordinates) and/or game results (e.g., win, loss, and/or other particular outcomes).
  • the game instructions 326 may comprise instructions for determining game-related output, actions, hints, codes, and/or results based upon prescription and/or prescription compliance events.
  • the game instructions 326 may also or alternatively comprise instructions relating to the control or operation of a separate device.
  • the game instructions 326 may cause the compliance module 310 and/or the output device 320 thereof to communicate with and/or control another device such as a TV.
  • the game instructions 326 may cause the compliance module 310 to send a signal to the TV to turn the TV off, disable video inputs to the TV (such as video game console inputs), or to cause a "V-chip" in the TV to block certain types or instances of programming.
  • compliance events such as taking a pill or medication may be scheduled to be coincident with a particular program, such as a favorite TV program, to further facilitate compliance (e.g., either by simply enhancing remembrance or by blocking the program unless the compliance event occurs).
  • the data storage device 322 may also or alternatively store the event data 330, the condition data 332, and/or the game data 334. Any or all of these and other types of data may be stored in any number, type, and/or configuration of data storage structures (such as the data storage structures described elsewhere herein) that is or becomes known.
  • the data storage device 322 may, for example, comprise one or more data tables or files, databases, table spaces, registers, and/or other storage structures. In some embodiments, multiple databases and/or storage structures (and/or multiple data storage devices 322) may be utilized to store information associated with the compliance module 310. According to some embodiments, the data storage device 322 may be incorporated into and/or otherwise coupled to the compliance module 310 (e.g., as shown) or may simply be accessible to the compliance module 310 (e.g., externally located and/or situated).
  • the event data 330 may comprise data associated with events detected, identified, and/or determined by the sensor 314. Events associated with the taking of a substance by a patient, for example, may be detected by the sensor 314 and recorded (e.g., as effectuated by the processor 312) as the event data 330.
  • the event data 330 associated with multiple events e.g., a months worth of pill bottle openings
  • the condition data 332 may also or alternatively be stored in the data storage device 322.
  • the condition data 332 may comprise, for example, data associated with prescriptions, therapies, and/or other health care regimens.
  • condition data 332 may define one or more conditions and/or time periods associated with such prescriptions.
  • the condition data 332 may be utilized by the processor 312, for example, to determine if detected events are compliant with the prescription conditions.
  • the game instructions 326 may only be executed (and/or may only produce positive results), for example, in the case that an event occurs that is complaint with the condition data 332.
  • either or both of the instructions 324, 326 and the data 330, 332, 334 stored in the data storage device 322 may be capable of being updated periodically as is desirable. As new prescriptions, games, and/or other information become available, for example, the data storage device 322 may be updated (e.g., via the input device 318).
  • the patient may utilize the compliance module 310 in conjunction with various prescriptions and/or prescription-related devices (e.g., pill bottles). Each time the patient goes back to the pharmacy he may be provided, for example, with a new pill container and new pills.
  • the patient may bring the compliance module 310, in some embodiments, so that data 330, 332, 334 and/or instructions 324, 326 stored in the data storage device 322 may be updated. In this way, revised prescription data may be conveniently entered.
  • the compliance module 310 may also or alternatively be in communication with a server such as the controller 150, so that any updates may be easily and/or automatically executed (e.g., wirelessly and/or remotely).
  • the game data 334 may comprise any game-related data that is or becomes known or practicable.
  • the game data 334 may, for example, include data indicative of one or more game boards (e.g., bingo boards, battleship boards, minesweeper and/or minesweeper-style boards), card decks (and/or shoes), maps, scratch tickets, and/or other game objects.
  • the game data 334 may also or alternatively include one or more moves, actions, values, results, outcomes, pay tables, probability tables, and/or other metrics associated with one or more games.
  • the game data 334 may comprise one or more files such as picture, sounds, movie, and/or other audio or video files.
  • the game data 334 may be utilized by the processor 312 in executing the game instructions 326.
  • the processor 312 may load one or more lottery and/or bingo numbers from the game data 334, for example, to be provided to a complaint patient via the output device 320.
  • FIG. 4A 1 FIG. 4B, and FlG. 4C 1 block diagrams of data tables 430, 432, 434 according to some embodiments are shown, respectively.
  • the data tables 430, 432, 434 may be similar in configuration and/or content to the data 330, 332, 334 and/or data tables described in conjunction with FIG. 3. Any or all of the data tables 430, 432, 434 may, for example, be stored in and/or otherwise associated with the compliance module 110, 310.
  • an event data table 430 may store event-related information
  • a condition data table 432 may store information associated with health care conditions
  • a game data table 434 may store game-related information, for example.
  • fewer or more data fields than are shown may be associated with the data tables 430, 432, 434. Only a portion of one or more databases and/or other data stores is necessarily shown in any of FIG. 4A, FIG. 4B, and/or FIG. 4C 1 for example, and other database fields, columns, structures, orientations, quantities, and/or configurations may be utilized without deviating from the scope of some embodiments. Similarly, the data shown in the various data fields is provided solely for exemplary and illustrative purposes and does not limit the scope of embodiments described herein.
  • the event data table 430 may comprise various data fields such as an "eventjd” field 430-1 , an “eventjype” field 430-2, and/or an “eventjime field” 430-3.
  • the "eventjd” field 430-1 may, for example, simply store an identifier for each event and/or event occurrence that is recorded in the event data table 430.
  • Each occurrence of an event detected by the sensor 314 may, for example, be represented by a unique identifier such as an alphanumeric code stored in the "eventjd" field 430-1.
  • Stored events may also or alternatively be identified and/or described by event types stored in the "eventjype" field 430-2. As shown in FIG. 4A, for example, various event types such as “cap_open”, “cap_closed”, and “patch_applied” may correspond to health care substance (e.g., medication and/or supplement) container openings and closing as well as medicated patch applications, respectively. Many other types of events may also or alternatively be stored and/or identified.
  • health care substance e.g., medication and/or supplement
  • event types may include, for example, container movements, changes in container weight (e.g., "pill_removed”), emptying or re-filling of a container, and/or use of various medical or health care-related devices (e.g., "inhaler_dosed” or “brace_engaged”).
  • container movements e.g., container movements, changes in container weight (e.g., "pill_removed")
  • emptying or re-filling of a container e.g., "pill_removed”
  • various medical or health care-related devices e.g., "inhaler_dosed” or "brace_engaged”
  • the time and/or date of every event may be recorded in the
  • the clock 316 may be utilized, for example, to determine a specific time (and/or time range or window) in which any given event occurs. Many ancillary time-related metrics may then, according to some embodiments, be calculated based on the stored time stamps.
  • any processing device (such as the processor 312) may simply calculate that the amount of time that the cap remained open was nine (9) seconds.
  • Such information may be advantageous to determine, for example, if the cap was accidentally opened (e g , the elapsed time may be determined to be too short for a patient to have removed a pill) and/or if the cap was accidentally left open (e g , a long period of time elapses before the cap is closed) It may also be advantageous simply to know when a substance and/or regimen was applied Certain medicines are more effective at certain times of the day, for example, and certain medications and/or therapies may not
  • the condition data table 432 may comprise various data fields such as a "conditionjd” field 432-1 , a “conditionjype” field 432-2, and/or a "cond ⁇ t ⁇ on_descr ⁇ pt ⁇ on” field 432-3
  • the condition data table 432 may store information associated with various conditions relating to prescriptions, therapies, and/or other health care regimens
  • the "conditionjd” field 432-1 may simply store an identifier (such as a unique identifier) for each recorded condition, for example, while the 'conditionjype' field 432-2 may store a classification and/or grouping associated with the conditions
  • some conditions may be associated with a "prescription”
  • others may be associated with "dietary” regimens
  • others may be less-stringent and/or simply "recommended ' conditions
  • Many other classifications may, of course, also or alternatively be practicable
  • condition "C-0100" (the first data record) defines a condition that a patient must take a pill once a day
  • a type, description, and/or identification of the particular pill (or other substance) associated with the condition may also be stored Such information may also or alternatively be accessible via a linked table such as a "prescription” and/or “medication” table (not shown)
  • the second condition “C-0101” is shown as indicating a "recommended” condition that the pill be taken during a time window between eight and nine in the morning
  • such "recommended” and/or secondary conditions may be utilized to provide rewards and/or specific game output to different patients While any patient satisfying condition "C- 0100" by taking a pill once a day may be deemed complaint, for example, those patients satisfying the 'recommended” condition “C-0101” may be considered “more” complaint and/or may otherwise be more highly rewarded (e.g., given more lottery
  • the game data table 434 may comprise various data fields such as a "gamejd” field 434-1, a “game_name” field 434-2, “game_data1” field 434-3, and/or a “game_data2" field 434-4.
  • the game data table 434 may store information associated with various games used to facilitate and/or enhance patient compliance with prescriptions and the related conditions stored in the condition data table 432.
  • the "gamejd” field 434-1 may simply store an identifier (such as a unique identifier) for each game, for example, while the "gamejiame” field 434-2 may store a name of each game.
  • the games shown in FIG, 4C, for example, are "bingo", “lotto”, and “minesweeper”. Many other games may also or alternatively be stored and/or used as described elsewhere herein.
  • the game data fields 434-3, 434-4 may store game output (such as the game output determined at 204 in the method 200) and/or other game-related data.
  • the exemplary records store multiple bingo numbers, lotto numbers, and coordinates, respectively. According to some embodiments, one of these numbers may be provided each time a patient performs a prescription-complaint act. In some embodiments, multiple game output numbers may be provided at any one given time. Accordingly, many game output values may be stored in many more game data fields than are shown in F)G. 4C.
  • a single game data field may be utilized that links to one or more other fields and/or tables that contain an appropriate amount of game output data.
  • the game data fields may simply comprise one or more random number seeds to be utilized by the processor 312 to generate game output (e.g., in accordance with the game instructions 326).
  • the compliance module 510 may be similar in configuration and/or functionality to any of the compliance modules 110, 310 described in conjunction with any of FIG. 1 and/or FIG. 3 herein.
  • the compliance module 510 may comprise, for example, one or more output devices 520a- b coupled to a container 582 and/or a cap 584 thereof.
  • the container 582 may, according to some embodiments, be or include any type or configuration of container such as a standard eight, sixteen, thirty, or forty dram (8, 16, 30, or 40-dr) amber clarified polypropylene prescription vial with a childproof, threaded, or snap cap, manufactured by Pharmacy Lite Packaging, Inc. or Pacific Management Holdings (PMH) Manufacturing and Design, LLC, both of Elyria, Ohio.
  • the container 582 may also, of course, comprise any form, shape, size, and/or configuration of container for storing and/or housing health care-related substances or devices that is or becomes known or practicable
  • the container 582 comprises a standard
  • a label 586 may be printed thereon and/or otherwise coupled thereto
  • the label 586 may, for example, display information such as patient information, pharmacy information, insurance information, and/or condition information 588
  • the condition information 588 may be similar to and/or include the condition data 332
  • fewer or more components that are shown in FIG 5A l O and/or FIG 5B may be included in or as part of the compliance module 510
  • the compliance module 510 may comprise alternate and/or various forms
  • the standard container 582 shown in FIG 5A and FIG 5B, for example, is exemplary in nature and does not limit the scope of the embodiments described herein
  • the compliance module 510 may be defined as a particular part or component of
  • the container 582 may comprise an entirely standard container with the compliance module 510 incorporated into the cap 584 and/or otherwise coupled thereto and/or associated therewith It should be understood that the procedures described herein such as the compliance facilitation procedures involving the output of game and/or other
  • the compliance module 510 may be utilized to identify, record, and/or otherwise determine whether a patient is compliant with various conditions (such as the condition 588) of a prescription
  • the compliance module 510 may, for example, identify various conditions (such as the condition 588) of a prescription
  • the compliance module 510 may also or alternatively provide game output to the patient (e g , at 206) to facilitate patient compliance with the prescription
  • the one or more output devices 520a-b of the compliance module 510 may be utilized to output game information such as information associated with the result of a game.
  • the result of a game may be output via an entertaining game interface, such as the slot machine interface shown in FIG. 5B, provided by the one or more output devices 520a-b. Having the result output via a game interface will further enhance, for example, the patient's enjoyment of obtaining the result of the game.
  • the label 586 may also or alternatively function as and/or be part of the one or more output devices 520a-b (e.g., the label may be comprised of material operable to output electronic messages, such as a flexible LCD, e-inkTM, and/or similar substances or materials).
  • the game interface and/or output may be provided, for example, via the label 586 and/or via more traditional LCD or other output devices 520a-b as shown in FIG. 5A and FIG. 5B.
  • the one or more output devices 520a-b may be included in, for example, (i) the cap 584 of the container 582; (ii) a cavity defined by the container 528 (not explicitly shown); (iii) the label 586 of the container 582; (iv) another portion of the container 582; (v) a peripheral device associated with the container 582 (not shown); or (vi) any combination thereof.
  • the one or more output devices 520a-b may comprise audio or video output devices (such as speakers or transmitters), printing devices, and/or one or more display devices such as an LCD and/or an LED screen.
  • the one or more output devices 520a-b comprise one or more display devices, for example, information such as still images (e.g., "winner") or animated images (e.g., spinning slot reels) may be shown.
  • the one or more output devices 520a-b may comprise two display screens 520a, 520b. It should be understood, however, that any number, type, or configuration of screens or other output devices 520a-b may be utilized, and that any output may be provided via any available output device 520 and/or any combination of available output devices 520a-b.
  • the first display screen 520a may provide a representation of a result of a game such as the slot machine interface shown, while the second display screen 520b may provide other output information such as game output, encoded game output, and/or encoded compliance data.
  • the result of a game provided by the first display device 520a may, for example, be represented by a plurality of symbols displayed along a payline, each symbol being displayed on the representation of a respective reel of a simulated slot machine. It should be understood that other interfaces based on other games or types of games may also or alternatively be used. Other games such as poker, solitaire, bingo, minesweeper, battleship, scratch tickets (such as scratch lottery tickets), and/or any other card, board, question, trivia, and/or video games that are or become practicable may be executed by the compliance module 510 and/or provided via the first display device 520a thereof.
  • the second display device 520b may display additional and/or other information to the patient.
  • the second display device 520b may display a telephone number for the patient to call, a description of a benefit to be provided to the patient that corresponds to the result of the game displayed via the first display device 520a, a warning (e.g., "take your pill within the next hour in order to remain eligible to win a prize"), and/or a compliance or game-related code that the patient may utilize to obtain rewards (e.g., by providing the code to the controller 150).
  • the patient may call a number provided by the second display device 520b, for example, to provide a code (e.g., also provided by the compliance module 510) to obtain and/or qualify for a reward.
  • the code may be displayed via the second display device 520b and may, for example, comprise a bingo or lotto number, a game coordinate, and/or other game-related information. Such information may be utilized by the patient, according to some embodiments, to conduct and/or participate in a game.
  • the game may be executed by the compliance module 510 and/or may be associated with external objects and/or devices.
  • the patient may utilize bingo numbers provided by the compliance module 510, for example, to play a bingo card.
  • the bingo card may be provided electronically via the first display device 520a and/or via an e-inkTM label 586, it may be printed on a standard label 586, engraved or etched on the container 582 and/or the cap 584, and/or may comprise a separate piece of paper or cardstock.
  • such cardstock (and/or label or other card or device) may comprise a latex overlay and/or layer configured to be at least partially scratched-off by a patient.
  • the scratch-off capability may be provided and/or simulated by a touch-screen device such as a flexible LCD display or the like.
  • the card stock and/or game board may comprise, for example, a small, thin, and/or disposable touch-screen device coupled to a processor and a battery (or other power source such as a small photovoltaic device), wherein the device is capable of simulating a scratch-style ticket or card.
  • a small, thin, and/or disposable touch-screen device coupled to a processor and a battery (or other power source such as a small photovoltaic device), wherein the device is capable of simulating a scratch-style ticket or card.
  • the latex layer, overlay, and/or simulated scratch area may be divided and/or segmented into multiple portions such as may be representative of the various portions of a bingo, minesweeper, minesweeper-type, and/or other game.
  • the portions may be separated by a margin to reduce the possibility that a patient may accidentally scratch-off an unintended portion
  • Each such portion may, according to some embodiments, be associated with one or more coordinates, codes, and/or game results
  • Patients may receive, for example, game output (e g , for performing compliance-related events) indicative of one or more portions of a game board defined by segmented portions The patients may then utilize the game output to identify particular portions of the game board to scratch-off
  • the latex may be scratched-off to reveal a game result such as a prize or value
  • patients may continue to scratch-off segmented portions until a negative result is revealed (e g , a mine) In such a manner, for example, patients may decide to continue to seek, upgrade, and/or accumulate winnings and risk voiding the game board (e g , by revealing a mine and/or other negative result), or may choose to redeem the game board for any currently-revealed prizes
  • the patient may be provided with a chance to win a prize each time the cap 584 is opened or closed in accordance with a condition of a prescription (e g , condition 588)
  • the compliance module 510 may, for example, comprise a random number generator, a processor (such as the processor 312), a sensor for detecting when the cap 584 is removed and/or replaced (such as the sensor 314), and/or a memory (such as the data storage device 322) - none of which are explicitly shown in FIG 5A or FIG 5B
  • the memory may store, for example, a probability table of available results (e g , symbol combinations to be displayed via the first display device 520a and/or coordinates to be provided via the second display device 520b), each result corresponding to at least one random number that may be generated by the random number generator
  • the memory may also or alternatively store a payout table of available prizes, each prize corresponding to one or more results that may be displayed via the first or second display devices 520a-b
  • the probability of winning a particular prize and/or the prizes available may be dynamic and/or may otherwise change For example, the longer a patient is compliant with prescription conditions (and/or the more compliant the patient is), the higher the probability of winning a prize may become In another example, more valuable prizes may be made available to patients of higher and/or longer compliance
  • the compliance module 510 may store information (e g , in the memory) identifying the patient and additional information associated with the identify of the patient that may be used to determine the probability to be used in determining a game result for the patient Such information may include, for example, an indication of the patient's current and/or past compliance with prescription conditions and/or requirements currently and/or previously associated with the patient In another example, such information may include an indication of the duration for which a condition has been associated with the patient (e g , if the patient has just begun a prescription, the patient may be provided winning game results more frequently to encourage the patient to become used to taking the medication as prescribed)
  • the compliance module 510 may be operable to communicate with another computing device (e g , the patient's PC)
  • the patient may download software that includes a game interface and that is operable to display game results based on information received from the compliance module 510
  • the compliance module 510 may transmit a code or other instruction to the PC that causes the software on the PC to provide a game result (e g , via an output device associated with the PC)
  • the compliance module 510 may transmit such code and/or other instruction via, for example, RF and/or Infrared Radiation (IR) signals, a cable connection between the compliance module 510 and the PC, and/or via the patient, who may be instructed to manually input the information into the PC
  • the compliance module 510 may not include a random number generator and/or table of game results in memory or be operable itself to display game results
  • the PC and/or other device associated with the patient e g , the user device 140
  • the PC and/or other device associated with the patient may comprise these elements and be operable to
  • the patient may be allowed to select one or more game interfaces and/or games via which results are to be displayed
  • the compliance module 510 may store more than one game and/or game interface in memory
  • different games from a plurality of stored and/or available games may be provided to the patient every time a game result is to be output
  • Various available games may, for example, be executed in a random order and/or in a round-robin fashion to maintain the interest of the patient
  • the compliance module 510 may be operable to determine one or more of the available games that the patient may desire, and these one or more games may be provided to the patient solely or more often than other available games
  • the user may be instructed to visit a Web site that has downloads of various games and/or game interfaces available and may select one of these for download to the memory of the compliance module 510
  • the patient may be asked (e g , by a pharmacist) to select a game and/or game interface when the patient takes possession of the compliance module 510 and/or obtains a refill and/or otherwise updates the compliance module 510 This selection information and/or other update information may, for example, be downloaded to the compliance module 510
  • different compliance modules 510 (such as different container caps 584) may be programmed with different games and/or game interfaces and the patient may be provided with the appropriate device based on the patient's selection of a game and/or game interface An appropriate device associated with a particular game may also or alternatively be supplied to patients based on demographic and/or other information (e g , to increase the likelihood that any given patient may find the provided game desirable) In some embodiments, to further motivate a patient to take their medicine and/or otherwise comply
  • a result of a game may be displayed for a predetermined length of time (e g , one hour) at and/or near a time associated with a prescription
  • a predetermined length of time e g , one hour
  • the compliance module 510 may display a result of a game between seven thirty (0730) and eight thirty (0830) in the morning of the current day
  • the patient will be handling the compliance module 510 and/or the container 582 during this one-hour period and will accordingly be provided with the game result
  • the game result is a winning one, the patient will be able to claim the associated prize
  • the patient fails to take the medicine as directed however, the patient will miss seeing the game result displayed during the one-hour period
  • Many patients will be motivated to remember to take their medicine as prescribed in order to avoid missing any potentially winning game results
  • the patient may instead build and/or accrue equity in a chance at a prize, improving a chance at winning a prize and/or increasing the value of an available prize with each opening or re-closing of the cap 584 (and/or with each other prescription-compliant action) For example, in one game a patient may win a prize if the patient obtains a predetermined number of occurrences of a particular slot reel symbol over a plurality of game results (e g ten cherries) Thus, each time the patient opens or re-closes the cap 584, the patient is hoping to obtain a game result that includes a cherry
  • the compliance module 510 may be operable to track the number of occurrences of the particular symbol the patient is attempting to collect In such an embodiment, the frequency of the appearance of the symbol the patient is attempting to collect may change
  • the symbol may appear more frequently when the patient first begins to collect the symbol, thus encouraging the patient to comply with a prescription
  • the probability of "winning" a game may otherwise generally be fixed, manipulated, and/or managed based on actions taken and/or actions that should be taken (e g , pursuant to a prescription) by the patient
  • the compliance module 510 may calculate probabilities based on the layout and bingo numbers already provided to the patient to determine one or more bingo numbers that should currently be provided to the patient
  • Other games may similarly be analyzed to determine the game output to be provided to the patient
  • the game output may be fixed and/or not dependent upon any particular criteria
  • the compliance module 510 may, for example, be preprogrammed to provide a certain fixed sequence of bingo numbers (and/or other game output) to the patient In some embodiments, these predetermined numbers may be pre-associated with a 'winning" bingo card, and the patient must simply comply
  • each time the patient opens or re-closes the cap 584 the patient may be provided with a chance to win a progressive jackpot In some embodiments, the patient may compete with other patients for the progressive jackpot Further, each time the patient opens or re- closes the cap 584 a contribution to the progressive jackpot may be made, such that the progressive jackpot increases over time
  • a discount or other benefit available to the patient may increase over time as the patient remains compliant, achieves a certain compliance level, and/or is otherwise deemed to be appropriately compliant
  • a discount in the patient's insurance co-pay, insurance deductible, and/or insurance premiums may increase by a predetermined amount for each predetermined period of time over which the acceptable and/or increased compliance is measured
  • the patient may be penalized for not complying with a prescription by, for example, a substantial reduction and/or removal of such a discount
  • a patient that has been compliant for an extended length of time and has thus earned a substantial discount will be quite motivated to remain compliant in order to maintain the level of discount that it took so long to earn and/or accrue
  • the patient may be provided with a chance to win a prize each time the patient opens or re-closes the cap 584 and also, in addition, be entered into a bonus game and/or pool for a chance to win a larger prize
  • the games playable by the patient may include games of skill and/or games that are part chance and part skill
  • a question game (such as a "trivia" game) may be made available via the compliance module 510
  • the questions for the game may be, for example, stored in the memory of the compliance module 510 and/or the memory of another computing device (e.g., the user device 140 and/or the controller 150) with which the compliance module 510 may be operable to communicate.
  • the questions may be related to the substance stored in the container 582 and/or to a prescription associated with the patient.
  • the patient may be asked (and/or otherwise presented with a question) whether the substance causes drowsiness, is to be taken with food, can be taken with alcohol, and/or is compatible with another substance.
  • the compliance module 510 may include an input device (such as the input device 318; not shown in FIG. 5A or FIG. 5B) via which the patient may provide answers to the questions.
  • one or more questions may be provided to the patient as a further requirement of claiming a prize. For example, assuming a winning game result has been output to a patient via the compliance module 510, the patient may be required to visit a Web site in order to input an indication of the winning result (e.g., an encrypted code output via the second display device 520b) and claim the associated prize. However, before the patient is allowed to claim the prize, the patient may be asked one or more questions. Such questions may, for example, be related to one or more medicines and/or other substances or devices that the patient currently has a prescription, therapy, and/or health care regimen for. In some embodiments, the questions may simply be trivia questions of any practicable and/or desirable nature or complexity.
  • questions may be asked of the patient to allow the patient to remediate previous acts of non-compliance.
  • a patient that misses one or more medication doses may be able to cure (and/or offset) the defects in compliance by successfully answering one or more questions related to the patient's prescription, likely consequences of missing doses, etc.
  • the remedial questions may comprise a test or quiz that the patient must pass (by achieving a certain pre-determined percentage of correct answers) in order to correct partial non-compliance.
  • the "passing score" required may be determined based on the severity of previous non-compliance.
  • a patient that has only missed a single dose may be required to answer one out of five questions correctly, for example, while a patient that has missed many doses may be required to answer ninety to one hundred percent (90-100%) of questions correctly, in some embodiments, "correction", “remediation”, and/or “offset” of non-compliance by answering questions or performing other acts may not "erase” non-compliance [e.g., the statistics of how often the patient took a medication may remain the same), but may preserve or recapture the patient's ability to win a prize or obtain a reward.
  • the output devices 520a-b of the compliance module 510 may output a number or set of numbers that the patient must match to a second number or second set of numbers known to the patient For example, the patient may win a prize if the number or set of numbers output via the compliance module 510 matches the prescription number of a prescription associated with the patient, the patient's social security number, and/or the patient's telephone number
  • a number and/or numbers output via the medicine container may be determined randomly, for example, such as in a manner similar to that described elsewhere herein
  • an input by the patient may be incorporated into the determination of a game result (e g , for added user enjoyment and further motivation to open the container 582)
  • a game result e g , for added user enjoyment and further motivation to open the container 582
  • the exact time at which the patient opens the medicine container may be incorporated into the determination of the random number used to determine the game result
  • the random number generator may continuously generate random numbers and the random number generated at the time of the cap 584 removal may be the random number used to produce the game result
  • the game results and/or indications of prizes may be provided to the patient via the compliance module 510 (and/or via another user-associated device), in accordance with some embodiments, the patient may be required to contact another entity and/or device (such as the controller 150) to obtain the game results and/or prize information or for further verification that the patient is in fact entitled to the prize indicated by the game result This may be the case, for example, for prizes with values over a predetermined value (e g , prizes worth more than twenty dollars) In some embodiments, the patient may need to provide additional verification and/or validation of having taken the substance as prescribed in order to collect a prize won based on a game result For example, prizes valued above a predetermined threshold may require such additional validation of compliance According to some embodiments, additional validation of compliance may comprise having the patient provide a code output by the compliance module 510, such as the compliance and/or game codes described in detail elsewhere herein
  • a patient attempting to redeem and/or obtain a large prize may be required to document compliance with a prescription by use of reagent test strips and/or other substance detection devices
  • a patient may be provided with a plurality of reagent test strips A test area of each reagent test strip may be impregnated with an appropriate indicator that reacts with a particular substance being tested for
  • the substance to be taken by the patient may, according to some embodiments, be coated with a quick-dissolving coating containing the substance being tested for
  • the patient may be provided with a second set of pills and/or other substances coated and/or impregnated with the substance being tested for.
  • a syrup and/or other ingestible and/or edible substance that includes the substance being tested for may, for example, be provided.
  • the patient may be required to ingest the second pill and/or other substance each time the prescription-related substance or medicine is taken, When the indicator reacts with the substance being tested for, a color change of the test area of the reagent test strip may occur.
  • the patient may be required to place a test strip into his mouth after taking the medicine and store the used test strips in an appropriate container. If and when the patient obtains a game result that corresponds to a prize of at least a predetermined value, the patient may be required to provide one or more of the used test strips as further proof of having taken the required substance.
  • a reagent test strip may be in the shape of a toothpick.
  • testing for a substance and/or reagent may be accomplished by a toilet and/or other common device outfitted with testing means.
  • a toilet at a testing facility may, for example, comprise physical and/or electronic devices to detect, measure, and/or indicate the presence of a substance.
  • Such devices may be as simple as an integrated test strip or indicator area (presumably a refillable and/or reusable area under the rim or in the bowl of a toilet) and/or may comprise one or more electrodes and a processing device to analyze electrode readings.
  • the effluent from the toilet may be analyzed by one or more devices coupled to the plumbing leading away from the toilet.
  • Such a device may, for example, be easily retrofitted onto and/or into existing plumbing systems such as those accessible via a basement, crawlspace, and/or utility closet of the patient, employer, insurer, and/or testing facility.
  • the substance being tested for may include a component that degrades or decomposes over time at a predetermined rate, such that a laboratory may be able to determine a length of time since a particular reagent test strip has been used. For example, a laboratory may be able to determine whether the patient used the reagent test strips over time as required or whether all the reagent strips were used at once (e.g., right before sending them into the laboratory), In yet another embodiment of how a patient may be required to further validate compliance, the patient may be required to visit a physician or laboratory for testing to verify that the patient has been taking the substance.
  • a physician or laboratory may collect a blood sample from the patient for analysis to determine whether the correct dosage of the substance is resident within the patient's bloodstream.
  • the patient may be provided with pills that each include a bar code imprinted thereon.
  • the patient may, according to some embodiments, also be provided with a bar code scanner (and/or a barcode scanner may be incorporated into the compliance module 510). In such an embodiment, the patient may be required to scan the bar code of each pill before ingesting the pill.
  • the patient may be required to provide the data from the bar code scanner to further verify compliance (e.g., by taking the bar code scanner or memory card of the bar code scanner to a pharmacy).
  • friends or relatives of a patient may be allowed to fund one or more prizes available to the patient.
  • a granddaughter may provide one hundred dollars ($100) to an entity to fund prizes for her grandmother (e.g., a patient).
  • the granddaughter may even be able to specify how the one hundred dollars ($100) is to be provided to her grandmother.
  • the granddaughter may specify that the one hundred dollars ($100) is to be provided as one large prize or distributed over a plurality of small, frequent prizes.
  • the granddaughter may also or alternatively be able to specify conditions upon which the funded prize will or will be likely (e.g., to a certain degree of probability) to be awarded to the grandmother.
  • the granddaughter may specify, fore example, that the grandmother must attain a compliance of at least eighty percent (80%) and/or maintain that level of compliance for one (1) month, in order to qualify for the funded prize.
  • the patient/grandmother may or may not be informed of the source for the funding of the prize.
  • Friends or relatives may also or alternatively be allowed to purchase a chance for the patient to win a relatively large prize. For example, a nephew may pay fifty dollars ($50) to obtain a chance for his uncle (e.g., a patient) to win a one million dollar ($1 ,000,000) jackpot.
  • the compliance module 510 may, for example, track the indication of the miss and the patient's acknowledgement of the miss before the taking of the next dose.
  • the compliance module 510 may incorporate this information in the next encrypted code and/or game-related output generated for the patient.
  • the patient may be provided with an opportunity to perform one or more tasks (e.g., taking a test and/or performing additional health-related activities) to make up for missed doses.
  • the compliance module 510 may also or alternatively provide remedial instructions to the patient based at least in part on the missed dosage.
  • missed dosage and/or treatment rules may be associated with taking vitamins, dietary supplements, and/or performing therapies This information may be provided via either or both of the output devices 520a-b, for example
  • a benefit for patient compliance may comprise an entry into a sweepstakes or a lottery
  • a process for providing a benefit to a patient may comprise the following steps ( ⁇ ) receiving an encrypted code comprising a patient identifier from a patient, (n) decrypting the code to determine the patient's compliance with a prescription, and if the patient is compliant, (in) entering the patient identifier in a sweepstakes, ( ⁇ v) drawing a patient identifier at random, and (v) providing a benefit to the patient associated with the drawn patient identifier
  • a patient's identifier may be entered into a sweepstakes more than once
  • a patient may be entered into a sweepstakes once per each "success "
  • a patient's number of entries may be based on the length of time the patient is compliant, the patient's "success percentage, ' etc
  • the system 600 may execute, perform, and/or may otherwise be associated with the method 200 described in conjunction with FIG 2
  • the system 600 may comprise, for example, the compliance module 610 and/or a container 682
  • the container 682 may comprise a cap 684 and/or a label 686
  • the compliance module 610 may comprise one or more detection areas 692
  • the components 610, 682, 684, 686 of the system 600 may be similar in configuration and/or functionality to the similarly named and/or numbered components described in conjunction with any of FIG 1 , FIG 3, FIG 5A, and/or FIG 5B
  • the compliance module 610 may, for example, be similar to the compliance modules 110, 310, 510 described elsewhere herein In some embodiments, fewer or more components than those shown in FIG 6 may be included in the system 600
  • the compliance module 610 may be or include a pressure-sensitive and/or other pad for facilitating increased patient compliance with prescriptions, therapies, and/or health care regimens
  • a pressure-sensitive and/or otherwise compliance-facilitating device may be referred to as a "compliance pad" (e g , a pad-style device that is operable to track and/or enhance patient compliance)
  • a compliance pad 610 is that it may be operable to facilitate compliance without requiring substantial and/or any modification to standard medicine and/or other containers 682 (and/or caps 684 thereof)
  • Electronic components may be substantially housed by and/or incorporated in the compliance pad 610, for example, while a substantially standard pill bottle and/or other container 682 may be utilized therewith
  • the compliance pad 610 may be utilized to easily track compliance with any or all such health care requirements without requiring substantial (or any) modifications to the multiple standard containers 682 used by the patient to store various health-related substances
  • the detection areas 692 of the compliance pad 610 may comprise one or more pressure-sensitive areas, for example, upon which standard containers 682 may be placed
  • the compliance pad 610 may function physically as a container stand (e g , to stabilize and/or otherwise hold or position the container 682), a coaster, a medicine cabinet and/or medicine shelf or drawer liner (or a shelf itself), and/or may otherwise serve as a location to place one or more health-related substances and/or devices
  • the compliance pad 610 may comprise a weight, mass balance, and/or motion sensor, such that the compliance pad 610 may be operable to (i) determine a first mass of the container 682 (including or not including the cap 684), (ii) detect a first movement and/or removal of the container 682 from the compliance pad 610, (iii) detect a second movement and/or a replacement of the container on the compliance pad 610, (iv) determine a second mass of the container 682, and (v) determine a difference between the first and second masses.
  • the compliance pad 610 may measure compliance by the removal of the container 682 from the compliance pad 610 and determining a change in the mass of the container 682 (e.g., indicating that an amount or quantity of a substance has been removed there from).
  • the detection areas 692 may be or include the weight, mass balance, motion, and/or other sensors (such as the sensor 314).
  • the detection areas 692 may comprise one or more electrical contacts and/or other sensors operable to determine whether the cap 684 of the container 682 is removed (and/or replaced).
  • the detection areas 692 may, for example, comprise a camera, a photocell, and/or a signal generator and/or receiver.
  • a camera may be pointed substantially vertically, for example, to capture images looking through the bottom of the container 682 toward the cap 684.
  • the images may then, according to some embodiments, analyzed to detect, identify, and/or otherwise determine changes between images that may indicate that the cap 684 is removed, replaced, and/or otherwise manipulated (e.g., twisted or depressed).
  • a photocell may similarly be directed to collect data through the bottom of the container 684 to detect changes in light levels that may indicate events associated with the cap 684.
  • Signals and/or beams such as radar, photo-optic, and/or IR beams may also or alternatively be directed through the bottom of the container 682 toward the cap 684.
  • the reflection, diffraction, and/or other characteristics of such beams may then be analyzed, for example, to determine if the cap 684 is removed, replaced, and/or otherwise manipulated.
  • such beams may be generated and/or otherwise emanate from the cap 684.
  • the detection areas 692 may then, for example, detect the characteristics and/or presence of such signal and/or beams to determine if the cap 684 is positioned on top of the container 682.
  • the detection areas 692 may also or alternatively comprise one or more electrical contacts.
  • the container 682 may also comprise electrical contacts (not shown), for example, that may couple to and/or otherwise engage the contacts of the detection areas 692.
  • the placement of the container 682 upon a detection area 692 may, for example, complete a circuit to indicate that the container 682 has been placed on the compliance pad 610.
  • such electrical contacts may also or alternatively indicate whether the cap 684 is coupled to the container 682.
  • An electrical contact of the cap 684 may, for example, couple to an electrical contact near the top of the container 682 to complete a portion of a cap-detection circuit
  • This cap-detection circuit may in turn be coupled via an electrical trace to a contact near the bottom of the container 682 that may engage and/or communicate with the detection areas 692 to indicate ( ⁇ ) the presence of the container 682, and/or (n) the coupling and/or presence of the cap 684
  • any or all of these electrical contacts and/or traces may be incorporated into the compliance pad 610, the container 682, and/or the cap 684, and/or may be coupled thereto via any techniques that are or become known or practicable Electrical traces of the container 682 may, for example, be incorporated into the label 686, such that a substantially standard container 682 may be easily modified to provide electrical indications to the detection areas 692
  • communication between the container 682, the cap 684, and/or the detection areas 692 may be partially and/or entirely wireless Passive induction devices may be utilized, for example, to allow the detection areas 692 to detect the presence and/or proximity of the container 682 and/or the cap 684
  • RFID devices may also or alternatively be utilized
  • Each container 682 and/or cap 684 may be equipped with an RFID tag, for example, that is capable of being either actively or passively detected by the detection areas 692
  • Such an RFID tag may indicate various information such as a unique identifier, container 682 and/or cap 684 data, and/or prescription or substance information (e g , type of substance and/or medication, expiration date, prescription rules, and/or compatibilities with other medications)
  • Such unique identification information may, according to some embodiments, be utilized by the compliance pad 610 to determine and/or indicate potential incompatibility of substances In the case that a patient taking multiple medications places two containers 682 on and/or near the compliance pad 610, for example, the detection areas
  • the compliance module 710 may execute, perform, and/or may otherwise be associated with the method 200 described in conjunction with FIG 2
  • the compliance module 710 may comprise, for example, one or more input devices 718a-c, one or more output devices 720a-c, and/or one or more detection areas 792a- e.
  • the input devices 718a-c may comprise a keypad 718a, a command button 718b, and/or directional controls 718c.
  • the output devices 720a-c may comprise a display screen 720a, a speaker 720b, and/or one or more LED devices 720c,
  • the components 718a-c, 720a-c, 792a-e of the compliance module 710 may be similar in configuration and/or functionality to the similarly named and/or numbered components described in conjunction with any of FIG. 3, FIG. 5A, FIG. 5B 1 and/or FIG. 6. In some embodiments, fewer or more components than those shown in FIG. 7 may be included in the compliance module 710.
  • the compliance module 710 may be similar in configuration and/or functionality to the compliance module 610 described in conjunction with FIG. 6. As shown in FIG. 7, for example, the compliance module 710 may be configured as a "compliance pad".
  • the compliance pad 710 may, according to some embodiments, be provided to a patient by an employer, a health care provider, and/or an insurance entity.
  • the compliance pad 710 may, for example, be associated with one or more health benefit, discount, and/or study programs associated with offered by a health insurance carrier. Applicants have realized, for example, that wellness programs such as the Healthy Rewards® program offered by CIGNA® may be advantageously supplemented via utilization of the compliance pad 710.
  • Such programs typically incorporate three (3) elements in an attempt to preemptively reduce health care costs. Patients are given incentives, for example, to (i) exercise, (ii) obtain regular physical examinations, and (iii) follow basic nutritional guidelines. The widespread and extremely expensive occurrence of non-compliance with prescriptions, therapies, and/or other health care regimens, however, has continued to prove difficult to address. Utilization of the compliance pad 710 and/or execution of the various procedures and/or other embodiments described herein, however, may prove to be an effective fourth element of wellness programs that may function to more effectively reduce health care costs and associated health care premiums (e.g., for individuals and companies alike).
  • the compliance pad 710 may be or include a pad-like device that is provided to insured patients as part of a wellness program.
  • the compliance pad 710 may be configured, according to some embodiments, to monitor patient compliance with a prescription and/or to provide game-related output to entice the patient to increase compliance.
  • the compliance pad 710 may be comprised of one or more flexible mediums such as a flexible Printed Circuit Board (PCB), a flexible LCD, rubber, plastic, and/or other flexible and/or semi-flexible materials.
  • the compliance pad 710 (and/or a portion thereof) may be comprised of foam, visco-elastic foam, glass, aluminum, steel, and/or a fabric such as polyester.
  • the compliance pad 710 may, for example, be similar in composition and/or flexibility to a mouse pad.
  • One advantage to a flexible compliance pad 710 may be that it is more easily transported (e.g., it may be rolled-up and/or folded) and/or more easily maintained (e.g., less subject to breakage or damage) than a rigid device. Any configuration of materials, shapes, sizes, and/or flexibilities that are or become desirable may, however, be utilized to define the compliance pad 710.
  • the compliance pad 710 may comprise the one or more input devices 718a-c,
  • the compliance pad 710 may comprise, for example, the keypad 718a, the command button 718b, and/or the directional controls 718c.
  • the keypad 718a may, according to some embodiments, comprise a standard layout of keys such as that utilized on most telephones and/or calculators. In some embodiments, the keypad 718a may be utilized by a patient to enter information into the compliance pad 710.
  • the patient may, for example, be able to configure preferences (e.g., contrast, colors, font, and/or modes) and/or customize the display screen 720a, enter information (e.g., prescription information, insurance information, and/or patient identification information), provide access codes such as a Personal Identification Number (PIN), and/or otherwise interact or interface with the compliance module 710.
  • enter information e.g., prescription information, insurance information, and/or patient identification information
  • PIN Personal Identification Number
  • the patient may be able to utilize the keypad 718a to provide game input (e.g., moves, commands, and/or other actions) to the compliance module 710.
  • game input e.g., moves, commands, and/or other actions
  • the command button 718b may also or alternatively be utilized to provide input to the compliance pad 710.
  • the "show code" command button 718b may be utilized by the patient to command the compliance pad 710 to show a code ⁇ e.g., via the display screen 720a).
  • the patient may utilize the command button 718b, for example, to cause the compliance pad 710 to display a compliance and/or game-related code such as those codes described elsewhere herein.
  • the patient may press the command button 718b to obtain a code that may be called-in to a health care entity to determine compliance, participate in a game, and/or to qualify for and/or receive prizes or other rewards.
  • the command button 718b may be utilized, for example, to obtain a compliance status (e.g., "complaint” or “non-compliant", or “70%") and/or a game status (e.g., "win! or "sorry”). In some embodiments, the command button 718b may not be included in the compliance pad 710 and/or may be incorporated into the keypad 718a.
  • a compliance status e.g., "complaint” or “non-compliant", or “70%”
  • a game status e.g., "win! or "sorry”
  • the command button 718b may not be included in the compliance pad 710 and/or may be incorporated into the keypad 718a.
  • the directional controls 718c may also or alternatively be included in the compliance pad 710.
  • the directional controls 718c may, for example, be utilized to provide direction-related input to the compliance pad 710. As shown in FIG. 7, for example, the directional controls 718c may be utilized to increase or decrease the volume of the speaker 720b. Other such input may also or alternatively be provided by the directional controls 718c.
  • the directional controls 718c may, for example, be utilized to provide directional input to play a game via the compliance pad 710 and/or to navigate menus provided via the display device 720a. Although only two directional controls 718c are shown in FIG. 7, it should be understood that fewer (e.g., a single multi-directional pad-style button) or more (e.g., a four-way grouping of controls) directional controls 718c may be included in the compliance pad 710.
  • the output devices 720a-c may be utilized to provide any of various types of output to the patient (and/or other entities).
  • the display device 720a may, as shown in FIG. 7 for example, provide indications of the time and date, a code, and/or game-related information (e.g., bingo numbers).
  • the code may comprise an encoded and/or encrypted compliance code indicative of the patient's compliance with a prescription, for example, while the game-related information may allow the patient to participate in a game (e.g., to entice the patient to interact with the compliance pad 710). Any other types of information that are or become practicable may also or alternatively be provided via the display screen 720a.
  • the display screen 720a may, for example, be utilized to provide a game interface such as a slot machine, video game, and/or trivia game interface.
  • the speaker 720b may also or alternatively be utilized to provide information to the patient (and/or another entity such as a pharmacist).
  • the speaker 720b may, for example, provide audible and/or spoken commands and/or alerts to the patient, such as "time to take medicine", “warning - incompatible medicines!, “game time!”, “please call-in the code", and/or "you have won!”.
  • the speaker 720b may, according to some embodiments, be utilized in conjunction with the display device 720a. In the case that the display device 720a provides and/or renders a game or game interface, for example, the speaker 720b may provide coordinated and/or attendant sounds and/or other audible game output.
  • the volume of the speaker 720b may be controlled via the directional controls 718c.
  • the compliance pad 710 may also or alternatively comprise the LED devices 720c.
  • the LED devices 720c may, for example, be utilized to provide visual indications to a patient and/or other entity.
  • a green LED device 720c may indicate current compliance, for example, and/or a red LED device 720c may indicate non-compliance and/or an error (e.g., low battery).
  • a combination of different colored LED devices 720c (such as shown in FIG. 7) may be utilized to provide many and/or more complex signals and/or output.
  • the LED devices 720c may be blinked and/or pulsed at various rates, in succession, in alternating succession, and/or may otherwise be activated, for example, to indicate any of a variety of practicable information, According to some embodiments, one or more LED devices 720c may be provided for each detection area 792a-e.
  • a green LED device 720c adjacent to a detection area 792a-e may indicate, for example, that a container is currently detected by the compliance pad 710 (e.g., via that particular detection area 792a-e), while a red LED device 720c and/or an inactive LED device 720c may indicate that no container is currently detected via the detection area 792a-e.
  • the detection areas 792a-e may be similar in configuration and/or functionality to the detection areas 692 described in conjunction with FIG. 6.
  • the detection areas 792a-e may, for example, comprise pressure-sensitive areas of the compliance pad 710. Any or all of the detection areas 792a-e may, according to some embodiments, comprise any type or configuration of sensor and/or detector that is or becomes known or available. In some embodiments, substantially an entire surface (such as the upper surface) of the compliance pad 710 may be pressure-sensitive.
  • the detection areas 792a-e may accordingly be designated areas of the pressure-sensitive compliance pad 710.
  • the keypad 718a and/or other input devices 718a-c may also or alternatively be incorporated as designated areas upon such as pressure-sensitive compliance pad 710.
  • the detection areas 792a-e may comprise one or more undesignated and/or unassigned areas.
  • the surface of the compliance pad 710 may be substantially unmarked and/or unassigned, for example, and a patient may simply place containers anywhere upon the surface to activate a single detection area 792.
  • multiple distinctly designated and/or marked detection areas 792a-e may be provided.
  • the detection areas 792a-e may be utilized to detect, track, weigh, and/or otherwise monitor or manage containers placed thereon. Some detection areas 792a-d may be configured and/or marked to monitor pill bottles and/or liquid vials, for example, while other detection areas 792e may be configured to monitor pill boxes, food containers, and/or other rectangular objects. Other configurations of detection areas 792a-e may also or alternatively be utilized. An "open" detection area with no distinct internal boundaries (such as described above) and/or other areas designed to accommodate bags and/or particular types of medical devices may also or alternatively be utilized, for example.
  • the detection areas 792a-d may be configured to provide output.
  • the first and second detection areas 792a-b are shown as being numbered, for example, to facilitate patient placement and/or organization of containers.
  • Such numbers may be printed on the surface of the compliance pad 710, for example, and/or may be displayed dynamically via embedded LCD and/or LED devices As shown with respect to the third detection area 792c, color-coding may also or alternatively be utilized
  • the patient may be provided with prescription vials of various colors and/or with various colored labels, for example, and the detection area 792c may be color-coded to correspond to one or more of the particular containers
  • Such color-coding may be printed directly on the compliance pad 710 and/or may be indicated by one or more lights such as color LED or LCD devices
  • a name and/or other identifier of a particular medicine may be displayed As shown with respect to the fourth detection area 792d, for example, the name "aspirin" may be displayed to indicate that an "aspirin" container should be placed on the fourth detection area 792d
  • the output-configured detection areas 792a-d may also or alternatively be utilized to provide game-related functionality Games such as "Simon says” and/or other color, pattern
  • the method 800 may be performed and/or implemented by and/or otherwise associated with the controller 150 described in conjunction with FIG 1
  • the method 800 may begin at 802 by receiving a code associated with a patient, wherein the code includes encoded information that is indicative of an occurrence of an event associated with the taking of a substance by a patient
  • the code and/or information may be recorded on a smart card and/or other storage medium and physically delivered to an entity for processing
  • a patient may receive such a code from a compliance device such as the compliance modules 110, 310, 510, 610, 710 described herein, and may call a number associated with a health care provider and/or insurer of the patient
  • the compliance module and/or pad may, for example, be provided to the patient by a health care provider, employer, insurance provider, and/or other entity (such as an entity that operates the controller and/or performs the method 800)
  • the patient may then, for example, provide a verbal and/or other indication of the code (e.g., input via a telephone keypad) to a controller and/or other receiving device or entity.
  • an Interactive Voice Response Unit (IVRU) associated with an insurance carrier and/or a third-party may, for example, receive the code from the patient.
  • the code may include information indicative of prescription-related statistics associated with the patient (e.g., a number of cap removals, amount of substance taken, or other patient actions) and/or may include an indication of a status and/or determination of compliance (e.g., such as in the case that a compliance module is provided with prescription-related conditions).
  • the code and/or information may also comprise time stamps, patient, compliance module, and/or account identifiers, tamper flags, and/or other such information, According to some embodiments, the code may also or alternatively comprise information indicative of game output and/or results.
  • the code and/or encoded information may, for example, indicate that the patient has won a game (e.g., associated with a compliance module).
  • the patient may be provided with a game board such as a Monopoly®, battleship, minesweeper, bingo, card game, and/or other game board, for example, and the code and/or encoded information may be indicative of a result and/or action associated with the game.
  • the patient may be awarded and/or provided with a prize.
  • the code itself may indicate a particular prize that the patient has won (and/or earned by being compliant).
  • the patient and/or compliance module may be actively solicited for the code.
  • the utilization and/or application of the information generated by a compliance module may be a substantially passive process (e.g., requiring little or no input or intervention on the part of the patient).
  • the controller may, for example, initiate a communication session with the patient such as by placing a phone call and/or sending an e-mail. This may occur, for example, at the end of a pre-designated compliance period, such as at the beginning or end of every month.
  • An automated voice system may, in some embodiments, prompt the patient for the code.
  • An operator and/or other device or entity may also or alternatively request the code from the patient and/or from the compliance module.
  • a response to the query may then be received.
  • the patient may enter the code via a touchtone telephone keypad, for example and/or speak the code into the telephone receiver.
  • the method 800 may continue by decoding the code to determine the information, at 804.
  • Various decoding and/or decrypting algorithms may be used, for example, to determine the encoded information based upon the received code.
  • different decoding and/or decrypting algorithms may be utilized for codes received from different patients and/or different compliance modules.
  • other information may be received (e g , at 804) in addition to the code itself
  • a public key and/or other decoding, identification, or routing information may, for example, be received and utilized to facilitate decoding or other processing of the code
  • the controller may retrieve decoding process instructions from a data storage device and then execute these instructions to decode the received data in order to derive one or more parameters indicative of the decoded data
  • the controller may execute the decoding process instructions to apply the same hash algorithm to the data to determine the associated hash value If the two hash values are the same, the data may, for example, be authenticated
  • the controller may additionally determine whether a positive tamper indication is present although this determination may be effected in a number of conventional ways, in the some embodiments, the determination may be made based on a tamper flag decoded from the received information In the case that the controller determines that tampering is evident, the controller may store an indication of such tampering in a database such as the data tables described elsewhere herein
  • the result of decoding may be provided to the patient, providing immediate feedback as to the receipt, content, and/or effect of the compliance and/or game data
  • This output may be provided, for example, in audio form via an IVRU and/or operator or via other electronic means (e g , e-mail)
  • the controller may additionally update stored patient data based on the decoded information For example, a patient record may be flagged to indicate that the patient has tampered with a compliance module and/or that data associated with the patient has been received
  • a code may be not be encrypted, but scrambled in some other manner (e g , the sum of all the digits of the code is determined to be less than ten, and the code is therefore valid)
  • a code may be expressed as and/or converted to a non-human-readable form ⁇ e g , a three-dimensional barcode) without requiring any other form of disguise and/or encryption
  • codes may not be encrypted, scrambled, encoded and/or otherwise secured at all
  • a code may, for example, simply correlate to a result stored by the controller that other entities (such as the patient) may be unable to find meaning in without access to the stored cross-reference table
  • the method 800 may continue at 806 by determining whether the occurrence of the event is compliant with a condition associated with the taking of the substance
  • the controller 150 may, for example, analyze the decoded information to determine a compliance associated with a patient
  • the actual compliance may already have been calculated and/or determined (e g , by a compliance module) and the controller may simply need to identify such results within the decoded information
  • the actions may be compared to various prescription conditions to determine levels of compliance
  • receipt of appropriately coded information may itself be deemed a "compliant" event, such as in the sense that by simply allowing the controller to monitor the patient's actions, the patient has been complaint
  • the patient may be provided with a compliance report
  • a compliance report may be generated to indicate ( ⁇ ) current compliance status, (n) compliance history (e g , during the compliance period and/or compared to previous compliance periods), (in) compliance goals, ( ⁇ v) suggestions for improving compliance, (v) rewards and/or prizes won or available (e g , due to achieved compliance), (v ⁇ ) encouragement messages from family and/or friends, (v ⁇ ) competition information (e g , ranks and/or standings of a patient and all other members of a certain group), and/or (vin) other compliance or patient-related information
  • Such a report may be very advantageous in analyzing a patient's compliance
  • the patient, the patient's health care provider (e g , doctor or nurse), the patient's insurer, and/or a third- party analysis entity may, for example, utilize the compliance report to manage and/or increase compliance, distribute
  • a patient may be provided with a code entitling the patient to a number of entries in a sweepstakes For example, for every five successes, the patient may be provided with an encrypted code, which the patient may "call in" to a sweepstakes telephone service controller.
  • a patient may be provided with a number of benefits (e.g., sweepstakes entries and/or lottery tickets or numbers) based on a compliance percentage (e.g., the number of successes divided by the number of elapsed time periods).
  • the value of a benefit e.g., discount amount, or sweepstakes jackpot
  • the reward given to a patient may be determined based at least in part on the compliance of other patients.
  • Patients may compete, for example, to obtain higher compliance ratings, with the most-compliant patient and/or patients receiving a reward or prize.
  • Groups of patients may also or alternatively compete together to obtain rewards.
  • Nursing home and/or other groups of patients may attempt to achieve group compliance goals, for example, to obtain a reward for the nursing home and/or for another associated third-party such as a charity.
  • compliance results may be available to competing patients such that patients may be more likely to view the current standings and attempt to achieve higher compliance to outperform other patients and receive rewards. Such compliance "races" may be quite useful in giving patients a competitive reason to increase prescription compliance.
  • a benefit may comprise a set of lottery numbers. For example, so long as a patient is compliant, the patient may be provided with several numbers every week for a state-drawn lottery. The numbers may be output, for example, via an output device associated with the compliance module.
  • an LED screen may depict five lottery numbers, as well as the date/time of the drawing and an encrypted code, which represents the date and the lottery numbers displayed to the patient. Should the numbers be winners, the patient may provide the encrypted code to a lottery agent so that the claim to winnings may be validated.
  • a medicine container may further comprise or be associated with a printer that may function to print a physical lottery ticket.
  • the patient may be allowed to select their own lottery numbers for a drawing.
  • the compliance module may output a code whenever the patient is eligible for an entry into a lottery drawing.
  • the patient may use the code to access a Web site, via which the patient may select a set of lottery numbers.
  • the Web site may first decrypt the code (e.g., at 804) to verify that the patient is in fact eligible to select the set of lottery numbers.
  • a patient may provide a set of preferred lottery numbers to the compliance module and/or to another entity (e.g., a pharmacist may download the selected numbers to the compliance module or the patient may register, with the controller, the selected set of numbers as associated with the patient via a Web site or other connection).
  • the patient may be provided with a code.
  • the patient may then call in this code to the controller and/or input the code into a Web site in order to have the preferred set of lottery numbers automatically entered into the next available lottery drawing.
  • the compliance module may be operable (e.g., via a modem) to communicate with the controller whenever the patient becomes eligible for an entry into a lottery drawing, in order to transmit to the controller an indication of the patient's eligibility. Upon receiving such an indication, the controller may automatically enter the patient's preferred set of lottery numbers into the next available lottery drawing.
  • a compliance module may comprise a random number generator.
  • each cap removal and/or other prescription-related event might trigger the generation of a random number.
  • a benefit may then be awarded based on a result associated with the random number [e.g., "You've won a Ford® ExplorerTM! Call 1-800-555-5555 and enter code 205034059").
  • the random number itself may be displayed to the patient. The patient may then determine the result associated with the random number by calling an entity such as the controller 150 with the random number and/or by visiting a Web site that displays the results associated with various random numbers.
  • the result associated with the random number may be displayed via an output device associated with the compliance module.
  • the data table comprising a list of random numbers and their corresponding results may be stored in a memory of the compliance module and/or another processor responsive to instructions from the compliance module.
  • the data table may be stored in the memory of a computing device (e.g., the user device 140 onto which appropriate software including the table has been loaded) and the compliance module may include an IR and/or RF-based output device via which the computing device may be instructed to access the table and display the result associated with the random number.
  • the patient may manually enter the random number into a computing device [e.g., the patient's PC or PDA onto which appropriate software including the table has been loaded), thus causing the computing device to display the result to the patient.
  • a "result" may comprise a representation or indication of a benefit to be provided to the patient.
  • a result may comprise a slot machine like collection of graphical symbols (e.g., cherry-cherry-cherry).
  • a data table may store a plurality of available results and the benefit (if any) associated with each respective result. This data table may be stored, for example, within a memory of the compliance module, within the memory of another computing device (e.g., the user device 140 onto which appropriate software including the table has been loaded), and/or the memory of the controller 150.
  • historical patient data may provide the basis for rewards or penalties, and could serve as a basis for making pricing decisions for future insurance coverage.
  • Patients might be provided with higher reimbursement levels for drugs for which they had complied with the prescription instructions, For example, a patient might pay one hundred ($100) for a prescription, with the insurance provider reimbursing one quarter (1/4) of that amount if the patient does not comply with the prescription requirements, and one half (1/2) of that amount if the patient does comply with the requirements. Insurance companies might also require that the patient call in with encoded data before any reimbursements are provided.
  • a compliance module may include processing instructions to store compliance statistics associated with a patient, and may output an encoded code only upon reaching a predetermined reward threshold.
  • encoding process instructions could include code that outputs encoded data only when the patient opens an associated pill or other container a number of times equal to the number of doses stored within the container.
  • a pharmaceutical supplier may offer rebates to purchasers of pharmaceuticals based on compliance and/or usage (e.g., as indicated by the encoded information).
  • a physician may also or alternatively provide a money back guarantee provided that a patient conforms to a prescription for a specified period of time.
  • a medical service provider such as a doctor, health maintenance organization and/or insurance company may offer preferred rates to their clients who consistently follow prescription instructions. By employing such embodiments, any medical service provider may easily, accurately, and securely verify prescription compliance.
  • FIG. 9 a block diagram of a controller 950 according to some embodiments is shown.
  • the controller 950 may be similar in configuration and/or functionality to the controller 150 described in conjunction with FIG. 1.
  • the controller 950 may, for example, be utilized to receive patient compliance and/or game information to provide rewards to patients.
  • the controller 950 may also or alternatively execute, process, and/or otherwise be associated with the method 800 described in conjunction with FIG. 8.
  • the controller 950 may comprise a processor 952, an IVRU 954, a communication device 956, an input device 958, an output device 960, and/or a data storage device 962.
  • the data storage device 962 may store decoding process instructions 964, game instructions 966, decoding data 970, patient data 972, and/or game data 974. In some embodiments, fewer or more components, instructions, and/or data than are shown in FIG. 9 may be included in the controller 950,
  • the processor 952 may be or include any type, quantity, and/or configuration of processor that is or becomes known,
  • the processor 312 may comprise, for example, an Intel® IXP 2800 network processor or an Intel® XEONTM Processor coupled with an Intel® E7501 chipset.
  • the processor 952 may comprise multiple interconnected processors, microprocessors, and/or micro-engines.
  • the processor 952 (and/or the controller 950 and/or other components thereof) may be supplied power via a power supply (not shown) such as a battery, an Alternating Current (AC) source, a Direct Current (DC) source, an AC/DC adapter, solar cells, and/or an inertia! generator.
  • a power supply such as a battery, an Alternating Current (AC) source, a Direct Current (DC) source, an AC/DC adapter, solar cells, and/or an inertia! generator.
  • the controller 950 comprises a server such as a blade server, necessary power may be supplied via
  • the IVRU 954 may, according to some embodiments, comprise one or more devices and/or coded instructions (e.g., software or firmware) capable of performing automated and/or substantially automated communications with one or more patients and/or other entities
  • the IVRU 954 may comprise, for example, a software package such as SpeechWorks® Call NavigatorTM powered by SpeakFreely® natural language technology, offered by ScanSoft® of Burlington, Massachusetts.
  • the processor 952 may receive signals from the IVRU 954.
  • the IVRU 954 may, for example, receive telephone calls and/or input from one or more patients.
  • the IVRU 954 may receive information indicative of compliance and/or game-related codes supplied to the patients by compliance modules, and/or may provide such information to the processor 952.
  • the IVRU 954 may also or alternatively initiate calls and/or other communications with a patient.
  • the IVRU 952 may, for example, initiate a call to a patient to solicit and/or request a compliance and/or game-related code (e.g., provided to the patient by a compliance module).
  • the communication device 956 may comprise any type or configuration of communication device that is or becomes known or practicable.
  • the communication device 956 may, for example, comprise a NIC, a telephonic device, a cellular network device, a router, a hub, a modem, and/or a communications port or cable.
  • the communication device 956 may be coupled to provide communications access to the IVRU 954.
  • the IVRU 954 may, for example, execute telephone and/or other voice or data communications with one or more patients via the communication device 956.
  • the communication device 956 may also or alternatively be coupled to the processor 952.
  • the communication device 956 may, for example, comprise a separate device from the IVRU 954.
  • the communication device 956 may, for example, comprise an IR, RF, BluetoothTM, and/or Wi-Fi network device coupled to facilitate communications between the processor 952 and another device (such as a compliance module).
  • the input device 958 and/or the output device 960 may comprise any types or configurations of input and output components and/or devices that are or become known, respectively.
  • the input device 960 may comprise, for example, a keyboard that allows an operator of the controller 950 to interface with the controller 950 (e.g., to program, monitor, and/or initiate IVRU 954 sessions).
  • the input device 958 may comprise a smart card and/or magnetic stripe card reader.
  • the input device 958 may, for example, allow a patient and/or pharmacist to swipe a card associated with a patient (e.g., a smart and/or magnetic stripe insurance card) to provide information such as encoded compliance and/or game-related information to the controller 950 and/or the processor 952.
  • the output device 960 may, according to some embodiments, comprise a display screen and/or other practicable output component and/or device.
  • the output device 960 may, for example, provide feedback to the patient or pharmacist that swipes a smart and/or magnetic stripe card via the input device 958.
  • the input device 958 and/or the output device 960 may be similar in configuration and/or functionality to the input device 318 and/or the output device 320 described in conjunction with FIG. 3 herein.
  • the data storage device 962 may, for example, store the decoding process instructions 964 and/or the game instructions 966 that may be utilized by the processor 952 to provide output information via the output device 958, the IVRU 954, and/or the communication device 956.
  • the data storage device 962 may comprise any appropriate information storage device that is or becomes known or available, including, but not limited to, units and/or combinations of magnetic storage devices (e.g., a hard disk drive), optical storage devices, and/or semiconductor memory devices such as Random Access Memory (RAM) devices, Read Only Memory (ROM) devices, Single Data Rate Random Access Memory (SDR-RAM), Double Data Rate Random Access Memory (DDR-RAM), and/or Programmable Read Only Memory (PROM).
  • RAM Random Access Memory
  • ROM Read Only Memory
  • SDR-RAM Single Data Rate Random Access Memory
  • DDR-RAM Double Data Rate Random Access Memory
  • PROM Programmable Read Only Memory
  • the decoding instructions 964 may be operable to cause the processor 952 to decode information.
  • Information received from any of the IVRU 954, the communication device 956, and/or the input device 958 may, for example, be decoded by the processor 952 in accordance with the decoding instructions 964.
  • encoded compliance and/or game-related information may be received from a patient and/or compliance module, for example, and may be decoded by the processor 952 executing the decoding instructions 964.
  • the data decoded by the processor 952 may comprise prescription compliance information
  • the number of cap, top, and/or ltd removals in a given time period may, for example, be decoded by the processor 952
  • other data may also or alternatively be decoded Examples of other data may include user identifiers, cap and/or container identifiers, insurance identifiers, account identifiers, compliance module identifiers, a beginning timestamp and an ending timestamp
  • the game instructions 966 may be operable to cause the processor
  • a patient may interface with the controller 950 (e g , via the IVRU 954, the communication device 965, and/or the input device 958) to play a game Access to such a game may be offered, for example, by a compliance module in the case that the patient complies with a prescription-related event and/or achieves some particular compliance goal
  • the compliance module may provide the patient with a telephone number and/or Uniform Resource Locator (URL) or other address via which the patient may access the controller 950 to play the game
  • the processor 952 may then execute the game instructions 966 to provide and/or render the game for the patient
  • the controller 950 may also or alternatively receive game-related information such as an encoded game code from the patient and/or compliance module The information may be decoded by the processor 952 (e g , executing the decoding instructions 964), for example, and then utilized to determine on or more game-related events and/or
  • a code received from a patient may trigger a particular game result for example, and/or may indicate that the patient is eligible for and/or has won a particular prize
  • the patient may play the game via the compliance module and/or another device (e g , an associated online game) and may provide a 'win" code associated with the patient's performance
  • the processor 952 may then, for example, execute the game instructions 966 to process the code and determine a result associated with the patient's performance achieved in playing the game
  • the game instructions 966 may simply direct the patient and/or the controller 950 to one or more other devices or Web sites associated with playing or downloading games
  • the data storage device 962 may also or alternatively store the decoding data 970, the patient data 972, and/or the game data 974 Any or all of these and other types of data may be stored in any number, type, and/or configuration of data storage structures (such as the data storage structures described elsewhere herein) that is or becomes known
  • the data storage device 962 may, for example, comprise one or more data tables or files, databases, table spaces, registers, and/or other storage structures In some embodiments, multiple databases and/or storage
  • the data storage device 962 may be incorporated into and/or otherwise coupled to the controller 950 (e g , as shown) or may simply be accessible to the controller 950 (e g , externally located and/or situated)
  • the decoding data 970 may comprise data associated with decoding information via the o decoding process instructions 964
  • the decoding data 970 may comprise, for example, one or more hash values, decryption keys, codes, and/or decoding or decryption algorithms
  • the patient data 972 may also or alternatively be stored in the data storage device 962
  • the patient data 972 may comprise, for example, data associated with patients and/or prescriptions, therapies, and/or other health care regimens associated with patients According to 5 some embodiments, the patient data 972 may comprise patient contact information, patient account information, medication data, and/or other patient-related information such as a history of prizes or other rewards won or achieved by patients
  • the game data 974 may comprise any game-related data that is or becomes known or practicable
  • the game data 974 may, for example, include data indicative of one or more game 0 boards (e g , bingo boards, battleship boards, minesweeper boards), card decks (and/or shoes), maps, and/or other game objects
  • the game data 974 may also or alternatively include one or more moves, actions, values, results, outcomes, pay tables, probability tables, and/or other metrics associated with one or more games
  • the game data 974 may comprise one or more files such as picture, sounds, movie, and/or other audio or video files
  • the game data 974 may be utilized by the processor 952 in executing the game instructions 966
  • the processor 952 may load one or more lottery and/or bingo numbers from the game data 974, for example, to be provided to a complaint patient
  • the data tables 1070, 1072, 1074 may be similar in configuration and/or content to the data 970, 972, 974 and/or data tables described in conjunction with FIG. 9. Any or all of the data tables 1070, 1072, 1074 may, for example, be stored in and/or otherwise associated with the controller 150, 950.
  • a decoding data table 1070 may store decoding-related information
  • a patient data table 1072 may store information associated with patients
  • a game data table 1074 may store game-related information, for example.
  • fewer or more data fields than are shown may be associated with the data tables 1070, 1072, 1074. Only a portion of one or more databases and/or other data stores is necessarily shown in any of FIG. 1OA, FIG. 10B, and/or FIG. 10C, for example, and other database fields, columns, structures, orientations, quantities, and/or configurations may be utilized without deviating from the scope of some embodiments. Similarly, the data shown in the various data fields is provided solely for exemplary and illustrative purposes and does not limit the scope of embodiments described herein,
  • the decoding data table 1070 may comprise various data fields such as a "compliancejnodulejd" field 1070-1, a
  • the "compliance_module_id” field 1070-1 may, for example, simply store an identifier for each compliance module that is issued and/or monitored by and/or otherwise associated with the controller 150, 950.
  • Each compliance module (such as a compliance pad) may, for example, be represented by a unique identifier such as an alphanumeric code stored in the "compliance_module_id" field 1070-1.
  • Each compliance module may also be associated with one or more patients represented by the "patientjd” field 1070-2. In such a manner, for example, compliance modules may be accurately associated with particular patients (and vise versa).
  • the "key" field 1070-3 may contain one or more cryptographic and/or other decoding keys, hash values, metrics, and/or algorithms. Such information may be utilized (e.g., via the decoding process instructions 964) to decode and/or decrypt information received from a compliance module and/or an associated patient. Different cryptographic information (e.g., public and/or private keys) may be stored for different compliance modules and/or patients, or multiple compliance modules and/or patients may be associated with standardized and/or universal cryptographic information.
  • cryptographic information e.g., public and/or private keys
  • the patient data table 1072 may comprise various data fields such as a "patientjd” field 1072-1, a “phone” field 1072-2, an "insurance Jd” field 1072-3, a “conditionjd” field 1072-4, a "tamper field 1072-5, a "score” field 1072-6, and/or a “rank” field 1072-7.
  • the patient data table 1072 may store information associated with various prescriptions, therapies, health care regimens, identification information, and/or other data associated with patients (e.g., patients participating in a wellness program).
  • the "patientjd" field 1072-1 may simply store an identifier (such as a unique identifier) for each registered patient.
  • the "patientjd" field 1072-1 may link to and/or be otherwise associated with the "patientjd” field 1070-2 of the decoding data table 1070.
  • Contact, identification, and/or demographic information associated with patients may be stored in various data fields as is desirable.
  • the "phone” field 1072-2 may, for example, store one or more telephone numbers and/or linking identification information (e.g., linking to other tables such as a telephone number table- not shown) associated with a patient. Other information may be similarly stored and/or linked to.
  • Insurance information (such as a health insurance account number) may be represented by and/or linked by the information stored in the "insurancejd" field 1072-3, for example.
  • Conditions associated with a patient's prescriptions may also or alternatively be stored and/or linked to via the patient data table 1072.
  • the "conditioned" field 1072-4 may, for example, link to a table (not shown) containing information describing conditions of a patient's prescriptions. This information may be utilized, for example, to determine if events associated with a patient are in compliance with a prescription.
  • the "conditioned" field 1072-4 may link to an external table such as via the "conditioned" field 432-1 of the condition data table 432 stored in some compliance modules.
  • a positive tamper indication associated with a patient via the "tamper" field 1072-5 may disqualify a patient from receiving prizes and/or rewards and/or may cause the patient to be otherwise penalized (e.g., charged a fee for damaging a compliance module).
  • the "score" field 1072-6 may contain information (such as the numeric information shown) indicating a score achieved by and/or otherwise associated with a patient.
  • the score may be a score representing compliance, for example, or may represent a patient's achievement in a game associated with facilitating compliance. According to some embodiments, the score may indicate a patient's score with respect to a competition between patients and/or groups of patients.
  • the "rank" field 1072-7 may, for example, show a ranking (e.g., based on the patient's score) of competing patients.
  • All patients in a particular geographical area e.g., a town, city, state, or zip code
  • employees of a particular office members of a particular insurance carrier, and/or members of other pre-defined groups (e.g., Internet groups, clubs, organizations) may, for example, compete for the best compliance (e.g., as represented by the score in the "score" field 1072-6) to win individual and/or group prizes.
  • the scores and/or rankings may be provided to the patients to further motivate increased compliance (e g , by stimulating competitive tendencies)
  • the game data table 1074 may comprise various data fields such as a "gamejd” field 1074-1 , a “gamejiame” field 1074-2, "w ⁇ n_code” field 1074-3, and/or a “prize” field 1074-4
  • the game data table 1074 may store information associated with various games used to facilitate and/or enhance patient compliance with prescriptions
  • the games may be played via a compliance module, a controller, and/or via another device
  • the "gamejd” field 1074-1 may simply store an identifier (such as a unique identifier) for each game, for example, while the "gamejiame” field 1074-2 may store a name of each game
  • the games shown in FIG 10C, for example, are "bingo", 'lotto", and “minesweeper" Many other games may also or alternatively be stored and/or used as described elsewhere herein
  • the "w ⁇ n_code" field 1074-3 may store one or more codes and/or other data associated with particular game outputs and/or results
  • a code of "ACE93" may be associated with a particular video poker result
  • this code is received from a patient (and/or decoded via information received from a patient), for example, a particular card, hand, and/or outcome may be provided to the patient (e g , via the compliance module and/or controller)
  • the code may indicate that the patient has "won" the game
  • a patient having complied with prescription requirements may have been presented with opportunities to play a video poker game via a compliance module, for example, and may have achieved a "winning” result in the game
  • the compliance module may generate a game code and/or an encoded version thereof and provide the game code to the patient
  • the patient may then communicate the game code to a controller that may decode the information and
  • an embodiment means “one or more (but not all) disclosed embodiments", unless expressly specified otherwise
  • a reference to “another embodiment” in describing an embodiment does not imply that the referenced embodiment is mutually exclusive with another embodiment (e g , an embodiment described before the referenced embodiment), unless expressly specified otherwise
  • the phrase "at least one of, when such phrase modifies a plurality of things (such as an enumerated list of things) means any combination of one or more of those things, unless expressly specified otherwise
  • the phrase at least one of a widget, a car and a wheel means either ( ⁇ ) a widget, (n) a car, (in) a wheel, ( ⁇ v) a widget and a car, (v) a widget and a wheel, (v ⁇ ) a car and a wheel, or (v ⁇ ) a widget, a car and a wheel
  • ordinal number such as “first”, “second”, “third” and so on
  • that ordinal number is used (unless expressly specified otherwise) merely to indicate a particular feature, such as to distinguish that particular feature from another feature that is described by the same term or by a similar term
  • a "first widget” may be so named merely to distinguish it from, e g , a "second widget”
  • the mere usage of the ordinal numbers “first” and “second” before the term “widget” does not indicate any other relationship between the two widgets, and likewise does not indicate any other characteristics of either or both widgets
  • the mere usage of the ordinal numbers “first” and “second” before the term “widget” (1) does not indicate that either widget comes before or after any other in order or location, (2) does not indicate that either widget occurs or acts before or after any other in time, and (3) does not indicate that either widget ranks above or below any other, as in importance or quality
  • the mere usage of ordinal numbers does not define a
  • a single device or article may alternatively be used in place of the more than one device or article that is described
  • a plurality of computer-based devices may be substituted with a single computer-based device
  • the various functionality that is described as being possessed by more than one device or article may alternatively be possessed by a single device or article
  • Devices that are in communication with each other need not be in continuous communication with each other, unless expressly specified otherwise On the contrary, such devices need only transmit to each other as necessary or desirable, and may actually refrain from exchanging data most of the time For example, a machine in communication with another machine via the Internet may not transmit data to the other machine for weeks at a time
  • devices that are in communication with each other may communicate directly or indirectly through one or more intermediaries
  • a description of an embodiment with several components or features does not imply that all or even any of such components and/or features are required
  • a variety of optional components are described to illustrate the wide variety of possible embodiments of the present ⁇ nvent ⁇ on(s) Unless otherwise specified explicitly, no component and/or feature is essential or required
  • process steps, algorithms or the like may be described in a sequential order, such processes may be configured to work in different orders In other words, any sequence or order of steps that may be explicitly described does not necessarily indicate a requirement that the steps be performed in that order The steps of processes described herein may be performed in any order practical Further
  • Determining something can be performed in a variety of manners and therefore the term “determining” (and like terms) includes calculating, computing, deriving, looking up (e g , in a table, database or data structure), ascertaining and the like
  • a "processor” means any one or more microprocessors, CPU devices, computing devices, microcontrollers, digital signal processors, or like devices
  • Non-volatile media include, for example, optical or magnetic disks and other persistent memory
  • Volatile media include DRAM, which typically constitutes the main memory
  • Transmission media include coaxial cables, copper wire and fiber optics, including the wires that comprise a system bus coupled to the processor
  • Transmission media may include or convey acoustic waves, light waves and electromagnetic emissions, such as those generated during RF and IR data communications
  • Common forms of computer-readable media include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, an EPROM, a FLASH-EEPROM, any other memory chip or
  • sequences of instruction may be delivered from RAM to a processor, ( ⁇ ) may be carried over a wireless transmission medium, and/or (in) may be formatted according to numerous formats, standards or protocols, such as BluetoothTM, TDMA, CDMA, 3G

Abstract

Certains modes de réalisation concernent des systèmes, des appareils, des procédés et des articles fabriqués destinés à un meilleur respect des soins de santé et consistant, par exemple, à identifier l'apparition d'un événement associé à la prise d'une substance par un patient, à déterminer des informations de sortie associées à un jeu et à fournir ces informations au patient. Dans d'autres modes de réalisation, les procédés peuvent consister à recevoir un code associé à un patient, le code comprenant des informations codées indiquant l'apparition d'un événement associé à la prise d'une substance par un patient, à décoder le code afin de déterminer les informations, à déterminer si l'apparition de l'événement est conforme à un état associé à la prise de la substance et à fournir, dans le cas où l'on détermine que l'état est conforme, une ou plusieurs récompenses au patient.
PCT/US2006/029420 2005-08-18 2006-07-27 Systemes et procedes destines a un respect ameliore des soins de sante WO2007021496A2 (fr)

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US60/709,254 2005-08-18
US11/225,240 2005-10-20
US11/255,240 US8092224B2 (en) 1995-11-22 2005-10-20 Systems and methods for improved health care compliance

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